[Federal Register Volume 83, Number 183 (Thursday, September 20, 2018)]
[Proposed Rules]
[Pages 47686-47762]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-19599]



[[Page 47685]]

Vol. 83

Thursday,

No. 183

September 20, 2018

Part II





Department of Health and Human Services





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Centers for Medicare & Medicaid Services





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42 CFR Parts 403, 416, 418, et al.





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

  Federal Register / Vol. 83 , No. 183 / Thursday, September 20, 2018 / 
Proposed Rules  

[[Page 47686]]


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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.

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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 (Sec.  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 (Sec.  485.66)
    H. Critical Access Hospitals
    I. Community Mental Health Center (Sec.  485.914(d))
    J. Portable X-Ray Services (Sec.  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

[[Page 47687]]

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 Sec.  
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 Sec.  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

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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 Sec.  418.112(f) to the 
``Written agreement'' standard at new Sec.  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 (Sec. Sec.  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 Sec.  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 Sec.  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 Sec. Sec.  482.68, 482.70, 482.72 
through 482.104, and at Sec.  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.

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k. Data Submission, Clinical Experience, and Outcome Requirements for 
Re-Approval of Transplant Centers
    We propose to remove the requirements at Sec.  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 Sec. Sec.  482.72 through 
482.104 and the data submission, clinical experience, and outcome 
requirements for initial Medicare approval under Sec.  482.80.
l. Special Procedures for Approval and Re-Approval of Organ Transplant 
Centers
    We propose to remove the requirements at Sec.  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 Sec.  
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 Sec.  486.104, ``Condition for coverage: 
Qualifications, orientation and health of technical personnel'', to 
align the current requirements at Sec.  486.104(a)(1), (2), (3), (4) 
with Sec.  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 
Sec.  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 Sec.  
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 Sec.  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 Sec.  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 Sec.  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 
Sec.  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 Sec.  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 Sec.  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.

[[Page 47690]]

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 Sec.  418.76(a)(1)(iv) to remove the 
requirement that a State licensure program meet the specific training 
and competency requirements set forth in Sec.  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 Sec.  
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 Sec.  483.10(f)(9) at 
Sec.  482.58(b)(1) (for hospital swing-bed providers) and Sec.  
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 Sec.  483.24(c) at 
Sec.  482.58(b)(4) (for hospital swing-bed providers) and Sec.  
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 Sec.  483.70(p) at 
Sec.  482.58(b)(5) (for hospital swing-bed providers) and Sec.  
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 Sec.  483.55(a)(1) at 
Sec.  482.58(b)(8) (for hospital swing-bed providers) and Sec.  
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 Sec.  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 Sec.  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 
Sec.  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):

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                                     Table 1--Summary of Costs and Benefits
----------------------------------------------------------------------------------------------------------------
                                                                                                     Estimated
                                                                                     Number of        annual
 Provider or supplier type and description of               Frequency                affected       savings or
              proposed provisions                                                    entities        benefits
                                                                                                    ($millions)
----------------------------------------------------------------------------------------------------------------
Religious Nonmedical Health Care Institution:
     Discharge Planning...............  As patients are discharged                    18             (*)
                                                 (Estimated 619 annual
                                                 discharges).
Ambulatory Surgical Center:
     Governing Body and Management....  Upon failed hospital transfer              5,557             (*)
                                                 agreement attempts.
     Patient Admission, Assessment and  Every patient admission to an          \1\ 5,557             454
     Discharge (History and Physical) **.        ASC or hospital outpatient.           \2\ 5,031
     Medical Records..................  Recurring annually..............           5,557               0
Hospices:
     Drugs and Biologicals, Medical     Recurring annually..............           1,151              80
     Supplies, and Durable Medical Equipment.
     Hospices That Provide Hospice      Recurring annually..............           4,602             (*)
     Care to residents of a SNF/NF or ICF/IID.
     Hospice Aide and Homemaker         Recurring annually..............           3,498               2
     Services.
Hospitals:
     Quality Assessment and             Recurring annually..............           5,031              28
     Performance Improvement Program.
     Medical staff: Autopsies.........  Recurring annually..............           5,031               0
     Infection Control................  Recurring annually..............           5,031             105
     Special requirements for hospital  Recurring annually..............           5,031              30
     providers of long-term care services
     (``swing-beds'').
     Special Requirements for           Recurring annually..............             574              62
     Psychiatric Hospitals.
Transplant Programs:
     Various provisions related to      Recurring annually..............             750           (\3\)
     performance ***.
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  Recurring annually..............           1,246              86
     providers of long-term care services
     (``swing-beds'').
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            Annual..........................             500              31
     technicians ***.
     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         Recurring annually..............          72,844              94
     Preparedness Program.
     Emergency Plan...................  Recurring annually..............          68,254               7
     Training and Testing-Training      Recurring annually..............          69,196              33
     Program.
     Training and Testing-Testing.....  Recurring annually..............          36,971               9
                                                                                 -------------------------------
        Total Annual Savings..................  ................................  ..............           1,123
        Life-extending benefits for transplant  ................................  ..............           (\3\)
         patients **.
----------------------------------------------------------------------------------------------------------------
* 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.


[[Page 47692]]

II. Provisions of the Proposed Regulations

A. Religious Nonmedical Health Care Institutions (RNHCIs)--Discharge 
Planning (Sec.  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 Sec.  
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, Sec.  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 Sec.  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 Sec.  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

[[Page 47693]]

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 (Sec.  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 Sec.  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 Sec.  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 Sec.  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 
Sec.  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 (Sec.  416.52(a)(1), 
(2), (3) and (4))
    The current regulations at Sec.  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

[[Page 47694]]

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 Sec.  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

[[Page 47695]]

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 (Sec.  416.47)
    The current regulations at Sec.  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 Sec.  416.52(a), we 
propose to revise the requirement at Sec.  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 Sec.  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 (Sec.  418.76)
    Under the current hospice CoP requirements at Sec.  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 (Sec.  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 Sec.  418.76(b) (training) and (c) (competency evaluation). At Sec.  
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 
(Sec.  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 Sec.  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 Sec.  
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 Sec.  418.76(b) and

[[Page 47696]]

(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 (Sec.  
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 Sec.  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 (Sec.  
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 (Sec.  418.56(b) through (d)), 
assure that the plan of care reflects patient and family goals (Sec.  
418.56(b) and includes all services (including aide services) necessary 
to manage pain and symptoms (Sec.  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 (Sec.  
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 (Sec.  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 (Sec.  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 (Sec.  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 (Sec.  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

[[Page 47697]]

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 Sec.  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 Sec.  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 Sec.  418.106(a)(1).
    Hospices would continue to be required to comprehensively assess 
patients on a regular schedule and on an as needed basis (Sec.  
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 (Sec.  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 Sec.  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 (Sec.  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

[[Page 47698]]

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 Sec.  418.112(f) and add a new 
requirement at Sec.  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 (Sec.  
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, Sec.  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 Sec.  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 Sec.  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

[[Page 47699]]

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-

[[Page 47700]]

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 Sec.  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 
(Sec. Sec.  482.22, 482.24, and 482.51)
Hospital Medical History and Physical Examination Requirements
    The current CoP at Sec.  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 Sec.  
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 Sec.  482.24, ``Medical Record Services,'' and Sec.  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'' (Sec.  
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 Sec.  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 Sec.  
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

[[Page 47701]]

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 Sec. Sec.  482.22, 482.24, and 482.51) would continue 
to apply and the proposed requirements for this CoP, as well as those 
proposed for Sec. Sec.  482.24 and 482.51, would not apply.
    For the current CoP at Sec.  482.24, ``Medical Record Services,'' 
we would revise the provisions at Sec.  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 Sec.  482.51, ``Surgical Services,'' contains 
provisions at Sec.  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 Sec.  
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 (Sec.  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, Sec.  
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 Sec.  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 
Sec.  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 (Sec.  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

[[Page 47702]]

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 Sec.  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'') (Sec.  482.58(b)(1), (4), (5), and (8), and 
Identical CAH Requirements: Sec.  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 Sec.  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 Sec.  485.645 for 
patients receiving swing-bed services.
    The hospital CoPs at Sec.  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 Sec.  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 Sec.  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 Sec.  
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:
     Sec. Sec.  482.58(b)(1) and (c) and 485.645(d)(1) 
(incorporating long-term care facility requirements at Sec.  
483.10(f)(9): Under our current regulations at Sec.  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 Sec. Sec.  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

[[Page 47703]]

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 Sec.  482.13 and CAHs providing swing-bed services at 
Sec.  485.645(d)(3) (which incorporates the long-term care requirements 
that patients be free from abuse, neglect and exploitation) would 
address such situations. We would monitor for any unintended 
consequences, as well as through evaluation of complaints that might be 
submitted regarding involuntary work performed by patients receiving 
swing-bed services in hospitals and CAHs. We would also ensure patient 
protections were maintained via the survey process and the process used 
to determine allegations of non-compliance with Federal or State 
requirements.
     Sec. Sec.  482.58(b)(4) and 485.645(d)(4) (incorporating 
long-term care facility requirements at Sec.  483.24(c)): The facility 
must provide, based on the comprehensive assessment and care plan and 
the preferences of each resident, an ongoing program to support 
residents in their choice of activities and the activities program must 
be directed by a qualified professional who is a qualified therapeutic 
recreation specialist or an activities professional.
    Similar to the requirements noted previously, we believe that this 
requirement is also unnecessary and burdensome for hospitals and CAHs, 
as patients receiving swing-bed services in a hospital or CAH are not 
long term residents of the facility and generally only receive swing-
bed services for a brief period of time for transition after the 
provision of acute care services. We expect that for those patients who 
receive swing-bed services for an extended period of time, their 
nursing care plan--as required under Sec.  482.23(b)(4) for hospitals 
and Sec.  485.635(d)(4) for CAHs--is based on assessing the patient's 
nursing care needs and will support care that holistically meets the 
needs of the patient, taking into consideration physiological and 
psychosocial factors.
     Sec. Sec.  482.58(b)(5) and 485.645(d)(5) (incorporating 
long-term care facility requirements at Sec.  483.70(p)): Any facility 
with more than 120 beds must employ a qualified social worker on a 
full-time basis.
    We propose to revise the requirements at Sec. Sec.  482.58(b)(5) 
and 485.645(d)(5) for hospitals and CAHs. The requirement that hospital 
and CAH swing-bed providers with more than 120 beds employ a full-time 
social worker is not applicable to either provider type. In accordance 
with the hospital and CAH swing-bed requirements, hospital swing-bed 
providers are not permitted to have more than 100 beds while CAH swing-
bed providers are not permitted to have more than 25 beds for the 
provision of inpatient or swing-bed services. Based on feedback from 
stakeholders, removing this requirement would eliminate confusion for 
providers and accreditation organizations.
     Sec. Sec.  482.58(b)(7) and 485.645(d)(7) (incorporating 
the long-term care facility requirement at Sec.  483.55(a)(1)): Under 
our long-term care facility requirements, the facility, must provide or 
obtain from an outside resource, in accordance with Sec.  483.70(g), 
routine and emergency dental services to meet the needs of each 
resident. We believe that this requirement is unnecessary and unduly 
burdensome for hospital and CAH swing-bed providers, as patients 
receiving swing-bed services in a hospitals or CAHs are not ``generally 
long term residents'' of the facility and are meant to receive swing-
bed services for a brief period of time for transition after the 
provision of acute care services. The American Dental Association 
recommends regular dental checkups at least once a year for routine 
dental care for adults over 60 years of age. With an average length of 
stay in a hospital or CAH swing-bed of 11.4 days and an average daily 
swing-bed census of 2 patients, we believe that it is unlikely that 
there is a need for routine dental services that cannot be provided on 
an outpatient basis. We expect that any required dental services that 
necessitate immediate treatment would be considered an emergency and 
would be addressed accordingly. In addition, the American Dental 
Association recommends that routine dental care be obtained at least 
every 6 months, which greatly exceeds that average length of stay in a 
hospital or CAH swing-bed. However, hospitals and CAHs are required to 
provide care in accordance with the needs of the patient that have been 
identified in such patients' plans of care; this could include non-
emergency dental care. We expect that hospital swing-bed providers are 
currently addressing the emergent dental care needs of their patients 
under the existing hospital CoP at Sec.  482.12(f)(2), which requires 
that hospitals have written policies and procedures for appraisal of 
emergencies, initial treatment, and referral when appropriate. 
Similarly, we expect that CAH swing-bed providers are currently 
addressing the emergent dental care needs of their patients under the 
existing emergency services CoP at Sec.  485.618, which requires CAHs 
to provide emergency care necessary to meet the needs of its inpatients 
and outpatients. As a result, we believe that this portion of the 
requirement is duplicative, given the current CoP requirements.
    Contact: Kianna Banks, 410-786-3498.
6. Special Requirements for Psychiatric Hospitals (Sec.  482.61(d))
    Section 482.61(d) of our regulations, as finalized in the June 1986 
final rule (51 FR 22050), requires that progress notes be documented by 
the doctor of medicine (MD) or doctor of osteopathy (DO) responsible 
for the care of the patient and, when appropriate, others significantly 
involved in active treatment modalities. ``Others significantly 
involved in active treatment modalities'' has been interpreted as staff 
from other disciplines, such as rehabilitative therapy and psychology, 
which are significantly involved in active treatment modalities and 
interventions. The intent of this requirement is to assure that the 
patient's medical record contains documentation of the patient's 
response to treatment planning and course of treatment. This 
documentation also serves to apprise all staff about patient's progress 
and any new problems or regression. We believe that the intent of the 
requirement to record progress notes in the patient's medical record 
continues to be an appropriate regulatory requirement. However, we

[[Page 47704]]

believe that as currently written and implemented, this requirement 
requires clarification. We believe that non-physician practitioners, 
including physician assistants, nurse practitioners, psychologists, and 
clinical nurse specialists, when acting in accordance with State law, 
their scope of practice, and hospital policy, should have the authority 
to record progress notes of psychiatric patients for whom they are 
responsible. Therefore, we propose to allow the use of non-physician 
practitioners or MD/DOs to document progress notes of patient receiving 
services in psychiatric hospitals.
    Contact: Kianna Banks, 410-786-3498.
    We are seeking public comment on all of the proposed hospital 
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 hospitals 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 RFIs that were included in the following 2017 
prospective payment regulations for hospitals:
     FY 2018 Hospital Inpatient Prospective Payment System for 
Acute Care Hospitals and the Long-Term Care Hospital Prospective 
Payment System found at https://www.regulations.gov/docket?D=CMS-2017-0055.
     CY 2018 Outpatient Prospective Payment System/Ambulatory 
Surgical Center proposed rule (https://www.regulations.gov/docket?D=CMS-2017-0091).
     FY 2018 Inpatient Rehabilitation Facility Prospective 
Payment System (https://www.regulations.gov/document?D=CMS-2017-0059-0002).
     FY 2018 Inpatient Psychiatric Facilities Prospective 
Payment System (https://www.regulations.gov/document?D=CMS-2018-0053-0002).
    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.

E. Transplant Centers

    Transplant programs, located within a transplant hospital that has 
a Medicare provider agreement, provide transplantation services for a 
particular organ type. Transplant programs must comply with the 
transplant center CoPs, located at Sec. Sec.  482.72 through 482.104, 
and with the hospital CoPs. There are several types of transplant 
programs including heart, lung, liver, and kidney. Intestine, pancreas, 
and multi-organ transplants are performed within existing transplant 
programs. For the purposes of this discussion, we define a transplant 
center as a group of transplant programs that are located in a 
transplant hospital. A transplant program is a component of the 
transplant center, within a transplant hospital, that provides 
transplantation for a particular type of organ. Transplant programs are 
surveyed for compliance with the CoPs.
    This proposed rule uses the term ``transplant center'' when 
discussing the current requirements and language used in the 
regulations. In accordance with our proposed nomenclature change, 
discussed later in this proposed rule, the term ``transplant program'' 
is widely used throughout the preamble and in the proposed regulation 
text.
    Section 1881(b)(1) of the Act sets out our authority for the 
Secretary to prescribe regulations for facilities furnishing end stage 
renal disease care to beneficiaries, including renal transplant 
centers. Section 1861(e)(9) of the Act permits the Secretary to issue 
regulations for the health and safety of individuals furnished services 
in hospitals.
    In response to the relative scarcity of donated organs compared to 
the number of people on transplant waitlists and the critical need to 
use these limited resources efficiently, we published a final rule that 
established CoPs for transplant centers on March 30, 2007, (Medicare 
Program; Hospital Conditions of Participation: Requirements for 
Approval and Re-Approval of Transplant Centers To Perform Organ 
Transplants) which codified requirements for approval and re-approval 
of transplant centers. We also placed Medicare-approved transplant 
centers under the survey and certification enforcement process we use 
for all other providers and suppliers of Medicare items and services 
(72 FR 15198). The transplant center CoPs include data submission, 
clinical experience, outcome, and process requirements for approval and 
re-approval of transplant centers. The requirements focus on an organ 
transplant program's ability to perform successful transplants and 
deliver quality patient care, as evidenced by outcomes as well as sound 
policies and procedures. The CoPs include requirements to protect the 
health and safety of both transplant recipients and living donors.
    We have continued to review and analyze the effectiveness of the 
transplant center CoPs, the effects of interpretive guidance, and the 
data derived from surveys of transplant programs. We also received 
comments from various stakeholders within the transplant center 
community that detailed the impacts of the implementation of the CoPs 
on transplant programs and transplant recipients. Upon further review, 
and taking into account input from various stakeholders, we believe 
that it is appropriate and necessary to revise the transplant center 
CoPs in order to reduce provider burden, increase long-term savings to 
the Medicare program, and eliminate obsolete or unnecessary 
requirements, while also continuing to protect the health and safety of 
transplant recipients and living donors.
    Furthermore, we believe that revising the transplant center CoPs 
will positively impact organ donation and transplantation in the United 
States by increasing the number of transplants performed each year and 
increasing the organ utilization rate, for reasons we discuss in 
further detail below. According to the Organ Procurement and 
Transplantation Network (OPTN) 33,610, organ transplants were performed 
and 15,948 donors (both living and deceased) provided organs in the 
United States in 2016. However, as of the writing of this proposed 
rule, 117,104 people still need a lifesaving organ transplant in 2017 
(number represents total waiting list candidates, https://optn.transplant.hrsa.gov/, July 2017). While strides are being made to 
improve organ donation and increase the number of organ transplants in 
the United States, there continues to be a shortage of organs.
    Therefore, we propose to revise the transplant center CoPs, as 
follows:

[[Page 47705]]

1. Special Requirement for Transplant Centers (Sec. Sec.  482.68 and 
482.70)
    Section 482.68 generally describes the requirements that a 
transplant center must meet in order to participate in the Medicare 
program; section Sec.  482.70 sets out definitions of terms used in the 
regulations. Specifically, in addition to meeting all the CoPs as a 
hospital, a transplant center must meet the CoPs specified in 
Sec. Sec.  482.72 through 482.104 in order to be granted approval from 
CMS to provide transplant services. Throughout the regulation, we use 
terminology relevant to transplantation and organ procurement to 
describe transplant centers, programs, living donors, and transplant 
center recipients. Because the terminology currently used in the 
regulation is not consistent with current nomenclature used throughout 
the transplant community and by the OPTN, Scientific Registry of 
Transplant Recipients (SRTR), and the Department of Health and Human 
Services (HHS), we propose to update the terminology within the 
hospital regulation at part 482 and the transplant regulations at 
Sec. Sec.  482.68, 482.70, 482.72 through 482.104, and at Sec.  488.61, 
for clarification and consistency. Specifically, we propose a 
nomenclature change which would:
     Replace the term transplant ``center'' in the regulation 
language with transplant ``program'' (each organ type would be a 
transplant program). A transplant program is located within a 
transplant hospital that provides transplantation services for a 
particular type of organ. Since individual transplant programs are 
surveyed for compliance with the CoPs, using the term transplant 
program throughout the regulation better aligns with current surveyor 
practice and will reduce provider confusion. In order to provide 
further clarity, we are also proposing to update the definitions at 
Sec.  482.70.
     Consistently use Independent Living Donor Advocate (ILDA) 
throughout the regulation.
     Change ``beneficiaries'' to ``recipients''.
    Since these changes would make our terms consistent with the 
terminology utilized by the OPTN and the transplant community, we 
believe these proposed changes would reduce provider confusion.
2. Data Submission, Clinical Experience, and Outcome Requirements for 
Re-Approval of Transplant Centers (Sec.  482.82)
    Section 482.82 requires that transplant centers that are applying 
for Medicare re-approval meet all data submission, clinical experience, 
and outcome requirements in order to be re-approved. In the March 2007 
final rule (72 FR 15198), we also finalized these requirements for 
initial Medicare approval of transplant centers, as described in Sec.  
482.80. Since the publication of the final rule, several studies have 
been published that examine the impact of these requirements on 
transplantation and organ utilization in the United States. A 2016 
article published in the American Medical Association Journal of Ethics 
concluded that ``using measured outcomes for punitive purposes may have 
resulted in significant unintended consequences'' and that ``transplant 
professionals will, by necessity, adapt practice to minimize the risk 
of regulatory citation and loss of transplant volume'' which 
contributes to ``lower transplant rates (typically among higher-risk 
candidates)'' and increased organ discard of marginal organs. (Adler, 
Joel T. and Axelrod, David A. Regulations' Impact on Donor and 
Recipient Selection for Liver Transplantation: How Should Outcomes be 
Measured and MELD Exception Scores be Considered, AMA Journal of 
Ethics, Vol. Volume 18, Number 2: 133-142. Doi: 10.1001/
journalofethics.2016.18.02. pfor1-1602, February 2016.).
    Another study linked performance evaluations to transplant volume 
in kidney transplant centers. The authors observed that centers that 
had low performance evaluations were more likely to have fewer kidney 
transplants than other kidney transplant centers. The study stated that 
kidney transplant centers that were identified with poor outcomes ``may 
be more likely to have staff turnover which may lead to declines in 
transplant volume'' and ``[c]enters that have been evaluated with lower 
performance may generally become more conservative in overall 
acceptance rates of candidates and donor organs'' (Schold, JD, et al. 
The Association of Center Performance Evaluations and Kidney Transplant 
Volume in the United States. American Journal of Transplantation 2013; 
13: 67-75. doi: 10.1111/j.1600-6143.2012.04345, 2013.).
    Another study covering over 90,000 liver transplant candidates 
concluded that the transplant center regulations that were finalized in 
the March 2007 final rule (72 FR 15198) increased the likelihood that 
liver transplant candidates would be removed from the liver transplant 
candidate waitlist and that this policy change led to the sickest 
patients being increasingly ``denied this lifesaving procedure while 
transplant mortality risks remain unaffected.'' The study found that 
the 2007 regulations had the effect of altering waitlist management and 
clinical decision making, thereby increasing the removal of the sickest 
patients from the waitlist. The impacts were seen through a 16 percent 
increase in delisting of patients due to the severity of their illness 
after the implementation of the 2007 regulation, and likelihood of 
being delisted continued to increase thereafter. The authors concluded 
that the 2007 regulation, which aimed to improve patient outcomes, had 
the consequence of instead failing to show any benefit to liver 
transplant patients. The authors suggested that future national policy 
decisions consider rebalance of the waitlist and transplant outcomes 
scale (Dolgin, Natasha H. et al. Decade-Long Trends in Liver Transplant 
Waitlist Removal Due to Illness Severity: The Impact of Centers for 
Medicare and Medicaid Services Policy. Journal of the American College 
of Surgeons. Volume 222, Issue 6, Pages 1054-1065. DOI: http://dx.doi.org/10.1016/j.jamcollsurg.2016.03.021, June 2016.).
    Another study of kidney transplantation found that most of the 
increases in the discard rate from 1988 to 2009 could be explained by 
recovery of organs from an increasing donor pool and changes in 
``pumping'' or perfusion practices. ``However, the presence of an 
unexplained, residual increase suggests behavioral factors (e.g., 
increased risk aversion) . . . may have played a role.'' (Darren E. 
Stewart, et al. Diagnosing the Decades-Long Rise in the Deceased Donor 
Kidney Discard Rate in the United States. Transplantation. 2017; 101: 
575-587.).
    A different approach was taken in a recent study using data from 
2000 to 2015. This study found that by comparing donors from whom one 
only one kidney was discarded and the other was transplanted reasons 
for discard could be better assessed. In this study ``a large number of 
discarded kidneys were procured from donors whose contralateral kidneys 
were transplanted with good post-transplant outcomes.'' It found that 
when two kidneys were retrieved from a deceased donor, and one of the 
two was discarded and the other used in a transplant, it was often the 
case that these ``discarded organs could have possibly demonstrated 
excellent performance if transplanted'' and ``the use of even a 
fraction of them could substantially reduce the number of patients who 
never receive an organ.'' As for the cause of these discards, the 
authors analyzed several factors and stated that ``the current report 
card system for transplant centers in the

[[Page 47706]]

United States . . . creates a disincentive to broader organ acceptance 
for centers concerned about payment penalties'' and that ``realignment 
of [these] incentives to promote more appropriate utilization is a key 
factor in reducing discards.'' (Syed Ali Husain, et al. Characteristics 
and Performance of Unilateral Kidney Transplants from Deceased Donors. 
Clinical Journal American Society of Nephrology 13: 2018.)
    We also received comments and feedback from pertinent stakeholders 
in the transplant community that align with the conclusions of these 
studies. For instance, UNOS has presented at public meetings that up to 
\1/3\ of kidneys that are discarded could be successfully transplanted. 
Furthermore, the transplant community has noted that transplant 
programs may not use these kidneys due to the perception that they are 
of higher risk and that the utilization of these kidneys may lead to 
outcomes non-compliance under Sec.  482.82. These programs have avoided 
using these kidneys for fear of non-compliance with the CoPs and 
potential Medicare termination of the program, despite evidence to the 
contrary that demonstrates that the use of these kidneys would not pose 
a problem for transplant recipients. The transplant community has 
therefore concluded that the regulations have led to behavioral changes 
in organ selection and transplantation on patients with fewer 
comorbidities and lower risk. This has resulted in transplant programs 
potentially avoiding performing transplant procedures on certain 
patients and many organs going unused.
    While it was our intent to ensure quality of care in transplant 
programs with the implementation of the regulations in Sec.  482.82, we 
acknowledge that the final regulation may have caused unintended 
consequences that impact transplantation and transplant programs in the 
U.S. Given the findings of published studies and articles, and the 
public feedback we have received, we believe that it is appropriate to 
remove these requirements for re-approval of transplant programs in the 
Medicare program.
    Therefore, we propose to remove the requirements at Sec.  482.82 
that require transplant centers to submit data (including, but not 
limited to, submission of the appropriate OPTN forms for transplant 
candidate registration, transplant beneficiary registration and follow-
up, and living donor registration and follow-up), clinical experience, 
and outcome requirements for Medicare re-approval, and make conforming 
changes to Sec.  482.102(a)(5) ``Condition of participation, Patient 
and living donor rights'' and Sec.  488.61 ``Special Procedures for 
Approval and Re-Approval of Organ Transplant Centers.'' Although we 
propose to remove these requirements, we continue to strongly believe 
that transplant programs should focus on maintaining high standards 
that protect patient health and safety and produce positive outcomes 
for transplant recipients. Therefore, we will continue to monitor and 
assess outcomes, after initial Medicare approval, through the 
transplant and hospital QAPI programs. In addition, quality of care 
will be monitored by assessing the other transplant program CoPs, 
including Sec. Sec.  482.72 through 482.104. We also encourage 
transplant programs and their respective hospitals' QAPI programs to 
conduct thorough analyses of adverse events, document such events, and 
implement improvement activities to prevent recurrences. We further 
note that transplant programs must continue to comply with the CoPs at 
Sec. Sec.  482.72 through 482.104 and the data submission, clinical 
experience, and outcome requirements for initial Medicare approval 
under Sec.  482.80. We believe this proposal will eliminate provider 
disincentives for performing transplantations and will lead to 
increased transplantation opportunities for patients on the waitlist; 
improved organ procurement for transplantation; greater organ 
utilization; lifesaving effects, reduced burden on transplant programs; 
and reductions in costs to both public and private insurance.
    We are seeking public comment on the removal of this requirement.
3. Special Procedures for Approval and Re-Approval of Organ Transplant 
Centers (Sec.  488.61(f) Through (h))
    Section 488.61 describes the survey, certification, and enforcement 
procedures for transplant centers, including the periodic review of 
compliance and approval as set out at Sec.  488.20. Section 488.61(f) 
through (h) set out the process for our consideration of a transplant 
center's mitigating factors in initial approval and re-approval 
surveys, certifications, and enforcement actions for transplant 
centers. The provisions also set out definitions and rules for 
transplant systems improvement agreements. We propose to remove the 
requirements at Sec.  488.61(f) through (h) for mitigating factors and 
transplant systems improvement agreements for the re-approval process 
for transplant centers. This change is complementary to the proposed 
removal of Sec.  482.82, described previously. We believe that repeal 
of these paragraphs would significantly reduce transplant programs' 
regulatory burden by no longer requiring them to submit mitigating 
factors applications or enter into systems improvement agreements for 
outcomes non-compliance (for re-approval surveys, certifications, and 
enforcement actions for transplant programs). Transplant programs will 
continue to be afforded the opportunity to submit mitigating factors or 
to enter into transplant systems improvement agreements during the 
initial application process to the Medicare program under Sec.  488.61 
(f) through (h).
    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 transplant programs 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 Hospital Inpatient 
Prospective Payment System for Acute Care Hospitals and the Long-Term 
Care Hospital Prospective Payment System proposed rule. Public comments 
in response to this RFI can be found at the following link: 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: Alpha-Banu Wilson, 410-786-8687.

F. Home Health Agencies

    Home health services are covered for the elderly and disabled under 
the

[[Page 47707]]

Hospital Insurance (Part A) and Supplemental Medical Insurance (Part B) 
benefits of the Medicare program, and are described in section 1861(m) 
of the Social Security Act (the Act). These services, provided under a 
plan of care established and periodically reviewed by a physician, must 
be furnished by, or under arrangement with, a home health agency (HHA) 
that participates in the Medicare or Medicaid programs. Services are 
provided on a visiting basis in the beneficiary's home, and may include 
the following:
     Part-time or intermittent skilled nursing care furnished 
by or under the supervision of a registered professional nurse.
     Physical therapy, speech-language pathology, and 
occupational therapy.
     Medical social services under the direction of a 
physician.
     Part-time or intermittent home health aide services.
     Medical supplies (other than drugs and biologicals) and 
durable medical equipment.
     Services of interns and residents if the HHA is owned by 
or affiliated with a hospital that has an approved medical residency 
training program.
     Services at hospitals, skilled nursing facilities, or 
rehabilitation centers when the services involve equipment too 
cumbersome to bring to the home.
    Under the authority of sections 1861(o) and 1891 of the Act, the 
Secretary has established in regulations the requirements that an HHA 
must meet to participate in the Medicare program. These requirements 
are set forth in regulations at 42 CFR part 484, Home Health Services.
1. Patient Rights (Sec.  484.50(a)(3) and (c)(7))
    Section 484.50(a)(3) of the January 2017 HHA CoP final rule (82 FR 
4504), effective January 13, 2018, requires HHAs to provide verbal 
(meaning spoken) notice of the patient's rights and responsibilities in 
addition to the requirement to provide such notice in writing. Section 
1891(a)(1)(E) of the Act requires additional oral notice of rights for 
specified information as follows:
     All items and services furnished by (or under arrangements 
with) the agency for which payment may be made under Medicare,
     The coverage available for such items and services under 
Medicare, Medicaid, and any other Federal program of which the agency 
is reasonably aware,
     Any charges for items and services not covered under 
Medicare and any charges the individual may have to pay with respect to 
items and services furnished by (or under arrangements with) the 
agency, and
     Any changes to the charges or items and services set forth 
in the previous bullets.
    Section 1891(a)(1)(F) of the Act requires that HHAs provide the 
notice of patient rights in writing.
    The requirements at Sec.  484.50(a)(3) implement these statutory 
requirements, and require spoken notice of all patient rights, rather 
than limiting such notice to those rights specified in the Act. On July 
28, 2017, we published a proposed rule entitled ``CY 2018 Home Health 
Prospective Payment System Rate Update; Home Health Value Based 
Purchasing Model; and Home Health Quality Reporting Requirements'' (82 
FR 35270) that solicited public comments on ways to reduce regulatory 
burden. In response to this solicitation, we received feedback from HHA 
stakeholders that the requirement to provide verbal notice of all 
rights to patients and their representatives was overly burdensome to 
the HHA clinicians that would be required to discuss the notice with 
patients when they could be furnishing hands-on patient care during 
that time, and lacked evidence that such explanations would result in 
improvements to patient safety or care. Furthermore, comments received 
encouraged us to reexamine all burdens in the January 2017 HHA CoP 
final rule to weigh potential benefits against estimated costs.
    We believe that the concerns expressed by commenters have merit. In 
light of this information, we believe that any benefits of this 
requirement are outweighed by the burdens imposed by this requirement. 
For this reason, we propose to delete the requirement that HHAs must 
provide verbal notification of all patient rights. This change would be 
consistent with the notice of patient rights requirements for other 
outpatient provider types, such as hospices, ambulatory surgery 
centers, and community mental health centers, for which written notice 
of patient rights is the only requirement. We propose to limit the 
verbal notification requirements to those requirements set out in 
section 1891(a)(1)(E) of the Act for which verbal notification is 
mandatory. We propose to revise Sec.  484.50(c)(7) to implement this 
more limited verbal notification requirement. Revised Sec.  
484.50(c)(7) would require HHAs to verbally discuss HHA payment and 
patient financial liability information with each HHA patient as 
described above.
    This change would not prevent states or Accrediting Organizations 
(AOs) from independently establishing and enforcing verbal notification 
requirements for all patient rights for purposes other than the HHA 
CoPs, nor would it prohibit HHAs from providing such verbal 
notification of all patient rights in the absence of Federal 
regulation. Furthermore, this change would not alter the other 
requirements at Sec.  484.50(a), which requires HHAs to provide the 
notice of patient rights in writing, nor would it alter the 
requirements at Sec.  484.50(f), Accessibility, which requires HHAs to 
provide information to patients in plain language and in a manner that 
is both accessible and timely to: (1) Persons with disabilities in 
accordance with the Americans with Disabilities Act and Section 504 of 
the Rehabilitation Act, and (2) persons with limited English 
proficiency. While HHAs would no longer be required to provide a verbal 
notification of all patient rights, we would continue to expect that 
HHAs answer any questions from patients or their representatives 
regarding the content of the written notice of rights. We believe that 
this proposed change would continue to provide adequate notice to 
patients while reducing burden on HHAs.
2. Home Health Aide Services (Sec.  484.80(h)(3))
    Section 484.80(h)(3) of the January 2017 HHA CoP final rule (82 FR 
4504) requires that, when a supervisory visit identifies a deficiency 
in a home health aide's skills, the HHA must conduct, and the aide must 
complete, a full competency evaluation to assess all aide skills and 
identify any other skill deficiencies that were not identified while 
observing the aide performing care with a patient. In public comments 
submitted for the July 2017 proposed rule ``CY 2018 Home Health 
Prospective Payment System Rate Update'' (82 FR 35270), a commenter 
suggested that completing a full competency evaluation was overly 
burdensome for HHAs and aides. Although this comment was not submitted 
during the proposed rule public comment period for the HHA CoP proposed 
rule, we believe that the concern expressed by the commenter has merit. 
In light of this new comment, we reconsidered the requirement, and 
concluded that a full competency evaluation is unnecessary and overly 
burdensome when only certain skills have been identified as deficient. 
We propose to eliminate the requirement to conduct a full competency 
evaluation, and replace it with a requirement to retrain the aide 
regarding the identified deficient skill(s) and require the aide to 
complete a

[[Page 47708]]

competency evaluation related only to those skills. This targeted 
retraining and competency evaluation requirement would reduce the time 
spent completing competency evaluations and retraining efforts.
3. Clinical Records (Sec.  484.110(e))
    In the January 2017 HHA CoPs final rule (82 FR 4504), effective 
January 13, 2018, we finalized a requirement, codified at Sec.  
484.110(e), that an HHA must make available, upon request, a copy of 
the patient's clinical record at the next home visit, or within 4 
business days (whichever comes first). In response to the July 2017 
proposed rule solicitation of public comment on burden reduction via 
the CY 2018 Home Health Prospective Payment System Rate Update (82 FR 
35270), we received feedback from HHA stakeholders that this 
requirement was impractical for HHAs to comply with because providing 
the record at the next visit may not allow enough time for HHAs to 
create a physical or electronic copy of the clinical record content, 
provide that copy to the next visiting clinician who may not be 
scheduled to come into the HHA office prior to the visit due to the 
nature of home based care and the significant travel that HHA 
clinicians must do in order to make patient visits, and successfully 
deliver the copy to the patient. The comments suggested that the 4 
business day timeline was more practical and is an appropriate 
regulatory requirement. We agree that providing the record at the next 
visit is not practical or even possible in some cases. Furthermore, we 
agree that retaining the 4 business day timeframe is an appropriate 
regulatory requirement. Therefore, we propose to remove the requirement 
that the requested clinical record copy must be provided at the next 
home visit.
    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. 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 HHAs 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 Home Health Prospective Payment System Rate Update; Value-Based 
Purchasing Model; and Quality Reporting Requirements. Public comments 
in response to this RFI can be found at the following link: https://www.regulations.gov/docket?D=CMS-2017-0100. 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.

G. Comprehensive Outpatient Rehabilitation Facilities (CORFs)--
Utilization Review Plan (Sec.  485.66)

    Section 485.51 of our rules defines a Comprehensive Outpatient 
Rehabilitation Facility (CORF) as a nonresidential facility that is 
established and operated exclusively for the purpose of providing 
diagnostic, therapeutic, and restorative services to outpatients for 
the rehabilitation of injured, disabled, or sick persons, at a single 
fixed location, by or under the supervision of a physician. As of May 
2017, there were 188 Medicare-certified CORFs in the United States. 
Section 1861(cc)(2)(G) of the Act requires CORFs to maintain 
utilization review programs. Under this authority, the Secretary has 
established requirements at Sec.  485.66 with respect to such programs. 
Currently, Sec.  485.66 requires the CORF to have in effect a written 
utilization review plan that is implemented at least each quarter, to 
assess the necessity of services and promotes the most efficient use of 
services provided by the facility.
    We propose to amend the utilization review plan requirements at 
Sec.  485.66 to reduce the frequency of utilization reviews. We believe 
the requirement to implement a utilization review plan 4 times a year 
is overly burdensome and diverts staff from providing patient care. We 
propose to require the utilization review plan be implemented annually 
by the facility, which would allow an entire year to collect and 
analyze data to inform changes to the facility and the services 
provided. Changing the requirement from a quarterly to an annual review 
would not preclude the CORF from implementing their utilization review 
plan more frequently, if required by facility policy. We believe that 
an annual utilization review plan will serve as a useful measurement 
tool for the facility, and that the change from quarterly to annual 
would not negatively affect patient health and safety.
    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 CORFs 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 RFIs that were included in the 2017 payment regulations. 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.

[[Page 47709]]

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

H. Critical Access Hospitals

1. Organizational Structure (Sec.  485.627(b)(1))
    Current regulations at Sec.  485.627 require CAHs to disclose the 
names and addresses of its owners, those with a controlling interest in 
the CAH or in any subcontractor in which the CAH directly or indirectly 
has a 5 percent or more ownership interest, in accordance with 42 CFR 
part 420, subpart C. Section 42 CFR part 420, subpart C, sets forth 
requirements for providers, Part B suppliers, intermediaries, and 
carriers to disclose ownership and control information and sets forth 
requirements for disclosure of information about a provider's or Part B 
supplier's owners and those with a controlling interest.
    The disclosure of ownership provisions at 42 CFR part 420, subpart 
C, are also required under the provider agreement rules under 42 CFR 
part 489. The term ``provider agreement'' is defined in Sec.  489.3 as 
an agreement between CMS and a provider or supplier to provide services 
to Medicare beneficiaries and to comply with the requirements of 
section 1866 of the Act (Agreements with Providers of Services; 
Enrollment Processes). Providers must meet the terms of the agreement 
to be qualified to participate in the Medicare program.
    We propose to remove this disclosure requirement from the CAH CoPs 
as it is duplicative of requirements for the provider agreement. 
Specifically, disclosure of individuals with a financial interest in 
the CAH is a requirement under the provider agreement rules in Sec.  
489.12(a)(2) and must be completed during the provider enrollment 
process. This information must be disclosed on the provider's Medicare 
enrollment application (Form CMS-855A for CAHs) and the enrollment 
application must be updated with any changes, such as address changes, 
practice name or change of ownership of information and must be 
submitted to CMS. Also note that this is not a requirement in the 
hospital CoPs under 42 CFR part 482 because it is already a requirement 
in the provider agreement rules under Sec.  498.12(a)(2).
    Contact: Kianna Banks, 410-786-3498.
2. Provision of Services (Sec.  485.635(a)(4))
    Current regulations at Sec.  485.635 require CAHs to review 
policies and procedures annually. We believe that medical practice has 
evolved such that we can provide flexibility for facilities to review, 
correct, or change their policies and procedures. Based on our 
experience with medical care providers and information from 
organizations such as the Brookings Institution (https://www.brookings.edu/testimonies/improving-health-care-quality-the-path-forward/), the expanded use of Web-based information and resources has 
fundamentally changed patient care, medical practice, and education. It 
has enabled providers to easily adjust policies and procedures on an 
as-needed basis. We believe that a prescriptive requirement to review 
policies and procedures annually could be eliminated to allow providers 
to review biennially and update as necessary, or more frequently if 
needed. For example, we expect providers 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 Sec.  485.635(a)(4) requires a CAH to review its 
policies at least annually by the CAH's professional healthcare staff, 
including one or more doctors of medicine or osteopathy and one or more 
physician assistants, nurse practitioners, or clinical nurse 
specialists, if they are on staff under the provisions of Sec.  
485.631(a)(1). The policies that are reviewed must include the 
following:
     A description of the services the CAH furnishes, including 
those furnished through agreement or arrangement;
     Policies and procedures for emergency medical services;
     Guidelines for the medical management of health problems 
that include the conditions requiring medical consultation and/or 
patient referral, the maintenance of health care records;
     Rules for the storage, handling, dispensation, and 
administration of drugs and biologicals;
     Procedures for reporting adverse drug reactions and errors 
in the administration of drugs; and
     A system for identifying, reporting, investigating and 
controlling infections and communicable diseases of patients and 
personnel.
     Procedures that ensure that the nutritional needs of post-
hospital SNF inpatients are met in accordance with recognized dietary 
practices.
    Based on feedback from stakeholders, the prescriptive annual 
schedule can be burdensome or, in some situations, ineffective. 
Providers stated that they make annual, monthly and biannual changes to 
their policies. Some have stated that they make changes as needed or 
infrequently. They also stated that the time that it took to review the 
policies varied. Some stated it would take as little as 2 hours while a 
few stated a much longer period time such as a month, depending on what 
was being changed. We believe that taking a month would represent a new 
facility or a facility that is experiencing major restructuring. After 
a careful review of the varied responses, we propose to provide 
flexibility and reduce burden by revising the requirement at Sec.  
485.635(a)(4) to, at a minimum, only require a biennial review of 
policies and procedures. The 2-year review would not preclude a 
facility from conducting a review more frequently if needed or 
organizing the review such that it would be completed over a 2-year 
period. Based on our experience with other providers, we believe that 
this approach would allow CAHs to maintain their health and safety 
policies in such a manner as to achieve the intended outcomes for all 
patients. Thus, we propose to change the requirement at Sec.  
485.635(a)(4) from ``annual'' to ``biennial''.
    Contact: Mary Collins, 410-786-3189.

[[Page 47710]]

3. Special Requirements for CAH Providers of Long-Term Care Services 
(``Swing-Beds'') (Sec.  485.645(d)(1), (4), (5) and (8))
    The special requirements for CAH swing-bed providers are nearly 
identical to the requirements for hospital providers of swing-bed 
services. As a result, please refer to the discussion on the special 
requirements for hospital providers of swing-bed services under section 
II.D.3 for the details of the proposed changes for these requirements. 
We propose the following revisions to the CAH swing-bed requirements:
     Revision of Sec.  485.645(d)(1) to remove the cross-
referenced long-term care requirement in Sec.  483.10(f)(9), which 
requires that CAH swing-bed providers to offer residents the right to 
choose to or refuse to perform services for the facility and prohibits 
a facility from requiring a resident to perform services for the 
facility;
     Removal of Sec.  485.645(d)(4), which requires CAH swing-
bed providers to provide an ongoing activity program that is directed 
by a qualified therapeutic recreation specialist or an activities 
professional who meets certain requirements (cross-referenced long-term 
care requirement Sec.  483.24(c));
     Redesignation of paragraphs (d)(5) through (9) as (d)(4) 
through (8), respectively;
     Revision of Sec.  485.645(d)(4) (as redesignated) to 
remove the cross-referenced long-term care requirement Sec.  483.70(p), 
which requires that CAH swing-bed providers with more than 120 beds to 
employ a qualified social worker on a full-time basis; and
     Revision of Sec.  485.645(d)(7) (as redesignated) to 
remove the cross-referenced long-term care requirement Sec.  
483.55(a)(1), which requires CAH swing-bed providers to assist in 
obtaining routine and 24-hour emergency dental care to its residents.
    Contact: Kianna Banks, 410-786-3498.
    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 CAHs 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.

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

    On October 29, 2013, we published a final rule (78 FR 209) that 
established, for the first time, a set of requirements that Medicare-
certified CMHCs must meet in order to participate in the Medicare 
program. These CoPs ensure the quality and safety of CMHC care for all 
clients served by the CMHC, regardless of payment source. These 
requirements focus on a person-centered, outcome-oriented process that 
promotes quality client care. These CoPs are set forth at 42 CFR part 
485 and apply to all Medicare participating CMHCs.
    Medicare certified CMHCs provide services to a wide range of 
clients, from those needing partial hospitalization program (PHP) 
services to clients needing routine counseling. Partial hospitalization 
services are an intense level of services needed ``to improve or 
maintain the individual's condition and functional level and to prevent 
relapse or hospitalization. . . .'' (section 1861(ff)(2) of the Act). 
As written, the current standard at Sec.  485.914(d) requires the CMHC 
to update the client comprehensive assessment every 30 days regardless 
of the client's needs or treatment schedule. This 30 day update of the 
comprehensive assessment correlates with the CMS PHP payment 
regulations, requiring PHP clients to receive an updated active 
treatment plan every 30 days. Clients receiving PHP are more acute and 
typically receive care in the CMHC multiple days a week for several 
hours a day. The PHP client will have changing needs as they progress 
through their treatment plan; therefore, updating the assessment every 
30 days or sooner if the client's condition changes continues to be an 
important requirement for the PHP client.
    While the minimum 30 day update time fame at Sec.  485.914(d) is 
needed for clients receiving PHP services, we do not believe that this 
time frame requirement supports the needs of all CMHC clients. Clients 
that do not receive PHP services may be seen weekly or every 2 weeks, 
while others are only seen every 2-6 months for a medication follow up. 
Requiring an updated assessment every 30 days may not be practical for 
the non-PHP client, causing either additional visits or phone calls 
from the CMHC to the client to document ``no changes in the client's 
assessment''. This is not an efficient use of CMHC clinician or client 
time. Therefore, we propose to modify this standard at Sec.  
485.914(d)(1) to require that the CMHC update each client's 
comprehensive assessment via the CMHC interdisciplinary treatment team, 
in consultation with the client's primary health care provider (if 
any), when changes in the client's status, responses to treatment, or 
goal achievement have occurred, and in accordance with current 
standards of practice. Additionally at Sec.  485.914(d)(3), we propose 
to retain the minimum 30 day assessment update time frame for those 
clients who receive PHP services. We believe this proposed change will 
allow for the provider and client to choose a visit schedule that is 
appropriate for the client's condition and not cause extra work or time 
for documentation that is unnecessary. Ultimately, this proposed change 
may allow for greater flexibility for the provider and client, saving 
time for both.
    We 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 CMHCs 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

[[Page 47711]]

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

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

    Portable x-rays are basic radiology studies (predominately chest 
and extremity x-rays) performed on patients in skilled nursing 
facilities, residents of long term care facilities and homebound 
patients. Under the authority of section 1861(s)(3) of the Act, the 
Secretary has established the CfCs that the supplier of portable x-ray 
services must meet to participate in Medicare and Medicaid, and these 
conditions are set forth at Sec. Sec.  486.100 through 486.110. The 
portable x-ray CfCs set forth at Sec.  486.104 were originally 
published on January 10, 1969 (34 FR 388) and were redesignated on 
September 30, 1977 (42 FR 528260), and amended on April 12, 1988 (53 FR 
12015), August 30, 1995 (60 FR 45086), and November 19, 2008 (73 FR 
69942). The portable x-ray CfCs set forth at Sec.  486.106 were 
originally published on January 10, 1969 (34 FR 388) and were 
redesignated on September 30, 1977 (42 FR 52826) and further 
redesignated and amended January 9, 1995 (60 FR 2326), August 30, 1995 
(60 FR 45086), and November 16, 2012 (77 FR 69372). The November 2012 
revision to the portable x-ray requirements allowed nurse practitioners 
and non-physician providers acting within their scope of practice to 
order portable x-ray studies. The current regulations are inconsistent 
with other rules governing diagnostic studies, as described later in 
this section of this proposed rule. In order to improve consistency, we 
propose changes to both Sec.  486.104, Condition for coverage: 
Qualifications, orientation and health of technical personnel and Sec.  
486.106, Condition for coverage: Referral for service and preservation 
of records.
    At Sec.  486.104, Condition for coverage: Qualifications, 
orientation and health of technical personnel, the portable x-ray 
technologist must meet any one of four training and education 
requirements in Sec.  486.104(a)(1), (2), (3), or (4). The requirement 
focuses on the accreditation of the school rather than the competency 
of the individual. In contrast, Sec.  482.26(c)(2), referring to 
qualifications of radiologic technologists in hospitals, is focused on 
the qualifications of the individual performing services as permitted 
by State law. Additionally, Sec.  410.33(c), which sets forth the 
personnel requirements for non-physician personnel used by an 
independent testing facility to perform tests, requires that testing 
personnel, including x-ray technologists, must demonstrate the basic 
qualifications to perform the tests in question and have training and 
proficiency as evidenced by licensure or certification by the 
appropriate State health or education department. These two other 
regulatory requirements that govern the same type of technologists do 
not have any accreditation requirements. Based on our survey findings 
in hospitals, which have not identified widespread patient safety or 
quality of care concerns related to the training and education levels 
of technologists, we do not believe that removing the school 
accreditation requirement from the portable x-ray personnel 
requirements would negatively impact portable x-ray patient health and 
safety.
    We propose to remove the four training and education requirements 
for two reasons. First, paragraph (a)(1), and to some extent paragraph 
(a)(4), focus on the accreditation of the school where the technologist 
received training, instead of focusing on the qualifications of the 
technologist performing the diagnostic test. Radiologic technicians who 
practice in a hospital, and for whom there are no requirements to 
receive education and training by an accredited program, are legally 
allowed to perform any diagnostic imaging procedure, including computed 
topography scans, mammograms, sonograms, and many other procedures that 
are more complex and require more expertise than portable x-rays. In 
contrast, portable x-ray radiologic technicians typically perform basic 
x-rays of the limbs (hand, foot) and chest, and are limited in their 
duties by State scope of practice rules. For this reason we are 
aligning the current requirements at Sec.  486.104(a)(1), (2), (3), and 
(4) with Sec.  482.26(c)(2), which refers to qualifications of 
radiologic technologists in hospitals, and is focused on the 
qualifications of the individual performing services as permitted by 
State law. This change would not preclude state licensure entities and 
portable x-ray suppliers from establishing personnel requirements that 
are more stringent that the proposed Federal requirements.
    Second, paragraphs (a)(2), (3), and (4) establish different 
personnel qualifications based on the date that a technologist received 
his or her education and training. We do not believe that it is 
efficient or necessary to have varying qualifications based simply on 
the date that such training was received. We propose to replace these 
four different qualifications with a single, streamlined qualification 
that focuses on the skills and abilities of the technologist. We 
believe that removing school accreditation requirements and simplifying 
the requirements will reduce regulatory burden, streamline the hiring 
process, and widen the pool of individuals who may be employed by 
portable x-ray suppliers to perform portable x-ray services, 
particularly those individuals who received training through the 
military for performing portable x-rays, as military training programs 
are not accredited.
    Section 486.106(a)(2) contains specific requirements for the 
content of the order for portable x-ray services, and requires that 
physician or non-physician practitioners orders for portable x-ray 
services must be written and signed. The requirements at Sec.  
486.106(a)(2) are inconsistent with the order requirements at Sec.  
410.32, which also apply to portable x-ray suppliers, in two ways. 
First, the requirements at Sec.  486.106(a)(2) have different order 
content requirements. Second, the requirements at Sec.  486.106(a)(2) 
have the effect of limiting or precluding telephonic and electronic 
orders, which are often more efficient ordering methods. Section 410.32 
allows for the diagnostic service to be ordered in writing, by 
telephone, or by secure electronic methods. Although, Sec.  410.32 does 
not prescribe the form of an order. The Medicare Benefit Policy Manual 
(Pub. 100-02), chapter 15, section 80.6 provides additional guidance on 
Sec.  410.32, and states:
    ``An order may be delivered via the following forms of 
communication:
     A written document signed by the treating physician/
practitioner, which is hand delivered, mailed, or faxed to the testing 
facility; NOTE: No signature is required on orders for clinical 
diagnostic tests paid on the basis of the

[[Page 47712]]

clinical laboratory fee schedule, the physician fee schedule, or for 
physician pathology services;
     A telephone call by the treating physician/practitioner or 
his or her office to the testing facility; and
     An electronic mail by the treating physician/practitioner 
or his or her office to the testing facility.
    If the order is communicated via telephone, both the treating 
physician/practitioner or his or her office, and the testing facility 
must document the telephone call in their respective copies of the 
beneficiary's medical records. While a physician order is not required 
to be signed, the physician must clearly document, in the medical 
record, his or her intent that the test be performed.
    We propose to update Sec.  486.106 (specific to portable x-ray 
services) to cross reference the requirements at Sec.  410.32. We 
propose to retain the requirement that the portable x-ray order must 
include a statement on why it is necessary to perform a portable x-ray 
as opposed to performing the study in a facility where x-rays are more 
typically performed. This change would allow for portable x-ray 
services to be ordered in writing, by telephone, or by electronic 
methods. The change would also streamline the ordering process by 
avoiding the need to write two separate orders for the same study, one 
to meet the Medicare payment requirements in accordance with Sec.  
410.32 and its associated Manual guidance, and another to meet the 
content requirements of the regulation set forth at Sec.  486.106. We 
believe the proposed change would allow for additional ordering 
flexibility to streamline ordering practices while maintaining ordering 
and documentation requirements consistent with all other diagnostic 
testing.
    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 suppliers of portable x-ray services 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 
Revisions to Payment Policies under the Physician Fee Schedule and 
Other Revisions to Part B. Public comments in response to this RFI can 
be found at the following link: https://www.regulations.gov/docket?D=CMS-2017-0092. 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: Sonia Swancy, 410-786-8445.

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

1. Provision of Services (Sec.  491.9(b)(4))
    Currently, Sec.  491.9(b)(4) requires RHCs and FQHCs to have their 
patient care policies reviewed at least annually by the designated 
group of professional personnel who advise the RHC or FQHC in 
developing these policies (described at Sec.  491.9(b)(2)), and 
reviewed as necessary by the RHC or FQHC. We propose to reduce the 
frequency of policy reviews. We believe the requirement to review 
patient care policies annually is burdensome and diverts staff from 
providing patient care. We propose to require the patient care policies 
be reviewed on a biennial basis by the group of professional personnel. 
Changing the review requirement from annually to every other year would 
not preclude the RHC or FQHC from maintaining their current annual 
review, if they believe it is necessary or if it is required by 
facility policy. We believe that this approach would allow RHCs and 
FQHCs to maintain their health and safety policies in such a manner as 
to achieve the intended outcomes for all patients. Thus, we propose to 
change the requirement at Sec.  491.9(b)(4) from ``annual'' to 
``biennial''.
2. Program Evaluation (Sec.  491.11(a))
    The current requirement at Sec.  491.11(a) requires that the RHC or 
FQHC carries out, or arranges for, an annual evaluation of its total 
program. Some RHCs and FQHCs have reported to us that this requirement 
is burdensome and utilizes costly staff resources. We propose to revise 
the current requirement at Sec.  491.11(a) by changing the frequency of 
the RHC or FQHC evaluation from annually to every other year. The 
revised requirement would then require a biennial evaluation of its 
total program. Changing the program evaluation requirement from 
annually to every other year would not preclude the RHC or FQHC from 
conducting an evaluation more frequently or maintaining their current 
annual evaluation, if they believe it is necessary or if it is required 
by facility policy. Furthermore, the proposed changes would give the 
RHC or FQHC the flexibility to focus only on certain program areas, if 
they choose to do so, for the off year in-between required program 
evaluations. The proposed change would reduce the paperwork burden of 
the RHC or FQHC and allow clinicians to focus more on patient care. We 
believe that an evaluation of the RHC or FQHC's total program every 
other year is sufficient to ensure consistent quality of care, and that 
the change from annual to biennial would not negatively affect patient 
health and safety. We welcome the public's comments on these proposed 
changes.
    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 RHCs and FQHCs 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 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

[[Page 47713]]

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-2017-0105-0002.
     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.
    Contact: CAPT Jacqueline Leach, USPHS, 410-786-4282.

L. Emergency Preparedness for Providers and Suppliers

    On September 16, 2016, we published a final rule entitled, 
``Medicare and Medicaid Programs; Emergency Preparedness Requirements 
for Medicare and Medicaid Participating Providers and Suppliers'' (81 
FR 63860), which established national emergency preparedness 
requirements for Medicare and Medicaid participating providers and 
suppliers (referred to collectively as ``facilities'' in the subsequent 
section) to plan adequately for both natural and man-made disasters and 
coordinate with Federal, State, tribal, regional, and local emergency 
preparedness systems. In that final rule, we emphasized the need for 
facilities to maintain access to healthcare services during 
emergencies, safeguard human resources, and maintain business 
continuity and protect physical resources. A facility's emergency 
preparedness program must include the following elements:

 Risk assessment and emergency planning
 Policies and procedures
 Communication plan
 Training and testing

    After the publication of that final rule, we continued to review 
and analyze the final emergency preparedness requirements and pertinent 
stakeholder feedback. Upon further review, we believe that some 
emergency preparedness requirements could be modified or eliminated to 
reduce provider and supplier burden while continuing to maintain 
essential emergency preparedness requirements that preserve the health 
and safety of patients in the United States. The following proposals 
would simplify the emergency preparedness requirements, eliminate 
duplicative requirements, and/or reduce the frequency with which 
providers and suppliers would need to perform certain required 
activities. We note that the current emergency preparedness standards 
are similar amongst all provider and supplier types, with a few 
variations to account for differences in health care settings. For 
clarity in the discussion later in this section of this proposed rule, 
we often refer to the hospital regulatory citation and we include 
specific references to other provider or supplier types when necessary.
1. Annual Review of Emergency Preparedness Program (Sec. Sec.  403.748, 
416.54, 418.113, 441.184, 460.84, 482.15, 483.73, 483.475, 484.102, 
485.68, 485.625, 485.727, 485.920, 486.360, 491.12, and 494.62 (a), 
(b), (c), and (d))
    Facilities are currently required to annually review their 
emergency preparedness program, which includes a review of their 
emergency plan, policies and procedures, communication plan, and 
training and testing program. However, pertinent stakeholders continue 
to question whether an annual review of the emergency program is 
necessary or beneficial to the facility. In response to their comments, 
we are therefore proposing to change this requirement to require 
facilities to review their program at least every 2 years. This will 
increase the facility's flexibility to review their programs as they 
determine best fits their needs. We expect that facilities would 
routinely revise and update their policies and operational procedures 
to ensure that they are operating based on best practices. In addition, 
facilities should update their emergency preparedness program more 
frequently than every 2 years as needed (for example, if staff changes 
occur or lessons-learned are acquired from a real-life event or 
exercise).
    As noted in the Emergency Preparedness final rule (81 FR 63860), 
``. . . there are various infections and diseases, such as the Ebola 
outbreak in October, 2014, that required updates in facility 
assessments, policies and procedures and training of staff beyond the 
directly affected hospitals. The final rule requires that if a facility 
experiences an emergency, an analysis of the response and any revisions 
to the emergency plan will be made and gaps and areas for improvement 
should be addressed in their plans to improve the response to similar 
challenges for any future emergencies.''
    The Assistant Secretary for Preparedness and Response (ASPR) 
Technical Resources, Assistance Center, and Information Exchange 
(TRACIE) located at: https://asprtracie.hhs.gov/, is an excellent 
resource for the various CMS providers and suppliers as they seek to 
implement the emergency preparedness requirements. TRACIE is designed 
to provide resources and technical assistance to healthcare system 
preparedness stakeholders in building a resilient healthcare system. 
There are numerous products and resources located within the TRACIE 
website that target specific provider types affected by the emergency 
preparedness aspects of this proposed rule. While TRACIE does not focus 
specifically on the requirements implemented in this proposed 
regulation, this is a valuable resource to aid a wide spectrum of 
partners with their health system emergency preparedness activities. We 
strongly encourage providers and suppliers to utilize TRACIE and 
leverage the information provided by ASPR.

[[Page 47714]]

2. Documentation of Cooperation Efforts (Sec. Sec.  403.748(a)(4), 
416.54(a)(4), 418.113(a)(4), 441.184(a)(4), 460.84(a)(4), 482.15(a)(4), 
483.73(a)(4), 483.475(a)(4), 484.102(a)(4), 485.68(a)(4), 
485.625(a)(4), 485.920(a)(4), 486.360(a)(4), 491.12(a)(4), and 
494.62(a)(4))
    Facilities are currently required to develop and maintain an 
emergency preparedness plan that includes 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, including 
documentation of the facilities' efforts to contact such officials and, 
when applicable, of its participation in collaborative and cooperative 
planning efforts. Upon further review of this requirement, we believe 
that elements of this requirement are unduly burdensome on facilities. 
Therefore, we propose to eliminate the requirement that facilities 
document efforts to contact local, tribal, regional, State, and Federal 
emergency preparedness officials and facilities' participation in 
collaborative and cooperative planning efforts. Facilities will 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. We believe that eliminating this documentation 
requirement will reduce provider and supplier burden by not requiring 
facilities to demonstrate that they have contacted local, tribal, 
regional, State, and Federal emergency preparedness officials or 
participated in collaborative and cooperative planning in the 
community, while still requiring facilities to at least include a 
process for cooperation and collaboration. We continue to encourage 
facilities to participate, when available, in community cooperative and 
collaborative planning efforts and execute the training and testing 
requirements in Sec.  482.15 (d) for hospitals and similar parallel 
citations for other facilities.
3. Annual Emergency Preparedness Training Program (Sec. Sec.  
403.748(d)(1)(ii), 416.54(d)(1)(ii), 418.113(d)(1)(ii), 
441.184(d)(1)(ii), 460.84(d)(1)(ii), 482.15(d)(1)(ii), 
483.73(d)(1)(ii), 483.475(d)(1)(ii), 484.102(d)(1)(ii), 
485.68(d)(1)(ii), 485.625(d)(1)(ii), 485.727(d)(1)(ii), 
485.920(d)(1)(ii), 486.360(d)(1)(ii), 491.12(d)(1)(ii), and 
494.62(d)(1)(ii)
    Facilities are required to develop and maintain a training program 
that is based on the facility's emergency plan. This emergency 
preparedness training must be provided at least annually and a well-
organized effective training program must include initial training in 
emergency preparedness policies and procedures. We revisited the public 
comments received on the Emergency Preparedness proposed rule (81 FR 
63890 through 63891) and determined that requiring facilities to 
provide annual training may be unduly burdensome. We are therefore 
proposing to change this requirement to require that facilities provide 
training biennially or every 2 years, after facilities conduct initial 
training on their emergency program. In addition, we propose to require 
additional training when the emergency plan is significantly updated. 
For example, when a facility makes substantial changes to the 
procedures or protocols within the emergency plan, we would require 
additional training on the updated emergency plan. Other non-
significant updates, such as revisions to the communication plan 
regarding contact information for staff, could be sent in company 
memorandum or provided to the facility's staff through other means. 
These proposed changes give facilities additional flexibility to 
determine what is appropriate for their facility's or staff's needs 
while maintaining adequate readiness.
4. Annual Emergency Preparedness Testing (Sec. Sec.  403.748(d)(2), 
416.54(d)(2), 418.113(d)(2), 441.184(d)(2), 460.84(d)(2), 482.15(d)(2), 
483.73(d)(2), 483.475(d)(2), 484.102(d)(2), 485.68(d)(2), 
485.625(d)(2), 485.727(d)(2), 485.920(d)(2), 486.360(d)(2), 
491.12(d)(2), and 494.62(d)(2))
    Facilities are currently required to conduct exercises to test the 
emergency plan at least annually. The facility must conduct two 
emergency preparedness testing exercises every year. Specifically, 
facilities must:
     Participate in a full-scale exercise that is community-
based or when a community-based exercise is not accessible, an 
individual, facility-based. If the facility experiences an actual 
natural or-man made emergency that requires activation of the emergency 
plan (including their communication plan) and revision of the plan as 
needed), the facility is exempt from engaging in a community-based or 
individual, facility based full-scale exercise for 1 year following the 
onset of the actual event;
     Conduct an additional exercise that may include either a 
second full-scale exercise that is community-based or individual, 
facility-based or a tabletop exercise that includes a group discussion 
led by a facilitator.
    Upon further analysis of this requirement, and taking into account 
stakeholder feedback, we have determined that there is also a need to 
clarify and revise some of the requirements included in the Emergency 
Preparedness final rule (81 FR 63860). We propose to clarify our intent 
with regard to the types of testing exercises, specifically full-scale 
exercises and functional exercises. As noted in the Emergency 
Preparedness proposed rule (78 FR 79101), a full-scale exercise is a 
multi-agency, multijurisdictional, multi-discipline exercise involving 
functional (for example, joint field office, emergency operation 
centers, etc.) and ``boots on the ground'' responses (for example, 
firefighters decontaminating mock victims). We expect facilities to 
engage in such comprehensive exercises with coordination across the 
public health system and local geographic area, if possible. Moreover, 
a functional exercise examines or validates the coordination, command, 
and control between various multiagency coordination centers (for 
example, emergency operation center, joint field office, etc.). A 
functional exercise does not involve any ``boots on the ground'' (that 
is, first responders or emergency officials responding to an incident 
in real time). The term ``functional exercise'' more accurately 
reflects our intentions for the testing requirement in the Emergency 
Preparedness final rule (81 FR 63860). We believe that there are 
opportunities to reduce the burden for inpatient and outpatient 
providers to meet the testing requirement.
    For providers of inpatient services, we propose to expand the 
testing requirement options 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. As 
indicated in the Emergency

[[Page 47715]]

Preparedness proposed rule, ``A workshop resembles a seminar, but is 
employed to build specific products, such as a draft plan or policy 
(for example, a Training and Exercise Plan Workshop is used to develop 
a Multiyear Training and Exercise Plan)'' (78 FR 79101). Providers of 
inpatient services include RNHCIs, inpatient hospice facilities, 
Psychiatric Residential Treatment Facilities (PRTFs), hospitals, long-
term care facilities (LTCFs), ICFs/IIDs, and CAHs. We believe this will 
allow greater flexibility for inpatient providers to meet this 
requirement. We note that although RNHCIs provide inpatient services, 
we have determined that changing their existing requirements to make 
them consistent with this proposed provision will be unduly burdensome 
as they are currently required to conduct a paper-based, tabletop 
exercise at least annually.
    For providers of outpatient services, we believe that conducting 
two testing exercises per year is overly burdensome as these providers 
do not provide the same level of acuity or inpatient services for their 
patients. Therefore, we propose to require that providers of outpatient 
services conduct only one testing exercise per year. Furthermore, we 
propose to require that these providers participate in either a 
community-based full-scale exercise (if available) or conduct an 
individual facility-based functional exercise every other year. In the 
opposite years, we propose to allow these providers to conduct the 
testing exercise of their choice, which may include either a 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. Providers of 
outpatient services include ASCs, freestanding/home-based hospice, 
Program for the All-Inclusive Care for the Elderly (PACE), HHAs, CORFs, 
Organizations (which include Clinics, Rehabilitation Agencies, and 
Public Health Agencies as Providers of Outpatient Physical Therapy and 
Speech-Language Pathology Services), CMHCs, Organ Procurement 
Organizations (OPOs), RHCs, FQHCs, and ESRD facilities. Due to the 
nature of services provided by OPOs we propose to require that they 
have the option of providing either a tabletop exercise or workshop 
every year.
    Lastly, we propose to clarify the testing requirement exemption by 
noting that if a provider experiences an actual natural or man-made 
emergency that requires activation of their emergency plan, inpatient 
and outpatient providers will be exempt from their next required full-
scale community-based exercise or individual, facility-based functional 
exercise following the onset of the actual event. A facility's 
communication plan is part of their emergency plan, as is coordination 
with other community emergency preparedness officials (for example, 
emergency management and public health), and we expect that these 
elements, along with the completion of a corrective action plan, are 
part of the activation of their emergency plan.
    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 all Medicare and Medicaid participating 
providers and suppliers mentioned in this section 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 RFIs that were included in 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-2017-0062-000.
     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-2017-0105-0002.
     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.
    Contact: Kianna Banks, 410-786-3498.

III. Collection of Information Requirements

    Under the Paperwork Reduction Act of 1995 (PRA), we are required to 
provide 60-day notice in the Federal Register and solicit public 
comment before a collection of information requirement is submitted to 
the Office of Management and Budget (OMB) for review and approval. In 
order to fairly evaluate whether an information collection should be 
approved by OMB, section 3506(c)(2)(A) of the PRA requires that we 
solicit comment on the following issues:
     The need for the information collection and its usefulness 
in carrying out the proper functions of our agency.
     The accuracy of our estimate of the information collection 
burden.
     The quality, utility, and clarity of the information to be 
collected.
     Recommendations to minimize the information collection 
burden on the affected public, including automated collection 
techniques.
    We are soliciting public comment on each of the section 
3506(c)(2)(A)-

[[Page 47716]]

required issues for the following information collection requirements 
(ICRs).

A. Wages

    To derive average costs, we used data from the U.S. Bureau of Labor 
Statistics' May 2016 National Occupational Employment and Wage 
Estimates for all salary estimates (https://www.bls.gov/oes/2016/may/oes_nat.htm). In this regard, the following table presents the mean 
hourly wage, the cost of fringe benefits and overhead costs (calculated 
at 100 percent of salary), and the adjusted hourly wage.

                               National Occupational Employment and Wage Estimates
----------------------------------------------------------------------------------------------------------------
                                                                                                     Adjusted
                Occupation title                    Occupation      Mean hourly   Fringe benefit  hourly wage ($/
                                                       code        wage ($/hour)     ($/hour)          hour)
----------------------------------------------------------------------------------------------------------------
Healthcare Support Worker.......................         31-9099          $18.13          $18.13             $36
Physicians and Surgeons.........................         29-1060          101.04          101.04             202
Physicians and Surgeons, All Other..............         29-1069           98.83           98.83             198
Physicians, Psychiatrists.......................         29-1066           94.26           94.26             189
Surgeons........................................         29-1067          121.59          121.59             243
Registered Nurse (RN--Quality Improvement, Home          29-1141           34.70           34.70              69
 Care Coordinator, HealthCare Trainer, Quality
 Assurance Nurse, QAPI Nurse Coordinator,
 Infection Control Nurse Coordinator,
 Psychiatric RN)................................
Medical Secretary (Clerical, Administrative              43-6013           16.85           16.85              34
 Assistant).....................................
Administrative Services Manager (Facility                11-3011           47.56           47.56              96
 Director)......................................
Management Occupations (Director, Community              11-0000           56.74           56.74             114
 Relations Manager, Administrator)..............
Pharmacist......................................         29-1051           57.82           57.82             115
Medical and Health Services Manager                      11-9111           52.58           52.58             105
 (Administrator, Transplant Program Senior
 Administrator/Hospital Administrator/Medical
 and Health Services Managers, Program Director,
 Risk Management Director. QAPI Director, Organ
 Procurement Coordinator, Nurse manager,
 Director of Nursing, Nursing care facilities/
 skilled nursing facilities)....................
Managers, All Others(Administrator).............         11-9199           53.92           53.92             108
* Activities Specialist (Recreational                    29-1125           19.92           19.92              40
 Therapists, Nursing Care Facilities/SNFs)......
Internists (Medical Director, General Physician.         29-1063           97.04           97.04             194
Family and General Practitioner (Medical                 29-1062           96.54           96.54             194
 Director)......................................
Physical Therapist (Director of Rehab)..........         29-1123           41.93           41.93              84
Healthcare Social Worker (Social Worker)........         21-1022           26.69           26.69              53
Mental Health and Substance Abuse Social Worker          21-1023           23.02           23.02              46
 (Social Worker)................................
Nurse Practitioner (Clinician, Nurse                     29-1171           50.30           50.30             101
 Practitioner Outpatient Care Center)...........
Mental Health Counselor.........................         21-1014           22.14           22.14              44
Physician Assistant.............................         29-1071           49.08           49.08              98
Licensed Practical and Licensed Vocational               29-2061           21.56           21.56              44
 Nurses (Director of Nursing)...................
First Line Supervisors of Office and                     43-1011           27.83           27.83              56
 Administrative Support Workers (Office Manager)
Office Clerks, General (Clerical staff).........         43-9061           15.87           15.87              32
Secretaries and Administrative Assistants                43-6010           19.39           19.39              38
 (Clerical staff)...............................
Chief Executive.................................         11-1011           93.44           93.44             186
----------------------------------------------------------------------------------------------------------------
* Salary information used is for Nursing Care Facility/SNF industry. As indicated, we are adjusting our employee
  hourly wage estimates by a factor of 100 percent. This is necessarily a rough adjustment, both because fringe
  benefits and overhead costs vary significantly from employer to employer, and because methods of estimating
  these costs vary widely from study to study. Nonetheless, there is no practical alternative and we believe
  that doubling the hourly wage to estimate total cost is a reasonably accurate estimation method.

B. ICRs Regarding RNHCI Discharge Planning (Sec.  403.736(a) and (b))

    Section 403.736 will reduce the extensive requirements for an RNHCI 
to coordinate with other medical providers for post-RNHCI care. The 
discharge evaluation must include an assessment of a patient's capacity 
for self-care and information regarding the care once the patient 
leaves the facility. The nursing staff would need to prepare the 
patient and/or their caregiver for discharge. Most patients are 
discharged to home or to another facility that adheres to the same 
religious tenets. Although all patients must have a discharge planning 
evaluation, not all patients require a discharge plan. Based on recent 
claims data, there was a combined annual total of 619 beneficiaries 
that stayed in the 18 facilities.
    We estimate that the time currently required to develop and 
document discharge plans and activities is 1,238 burden hours (2 hours 
for each of the 619 beneficiaries discharged) and that it would be 
reduced by half. Of the approximately 619 annual discharges, we 
estimate that a RNHCIs burden would be reduced to one hour for each 
discharged individual. A RNHCI would not need to develop a discharge 
plan that includes medical care once a patient leaves the RNHCI because 
doing so would not be in keeping with the religious tenets of the 
patients they serve. We estimate that the healthcare support worker 
responsible for a patients discharge plan is paid at mean wage of $36, 
including 100 percent for fringe and overhead costs. Based on our 
experience with RNHCIs, we estimate that it would take 1 hour to 
develop the proposed discharge instructions and discuss them with the 
patient and/or caregiver. We estimate a total of 619 annual discharges 
from RNHCIs at a savings of $36 per discharge for a total savings of 
$22,284 ($36 x 619 hours).

[[Page 47717]]

C. ICRs Regarding ASC Governing Body and Management (Sec.  
416.41(b)(3)(i) and (ii))

    We propose to eliminate the requirements at Sec.  416.41(b)(3) that 
states the ASC must have a written transfer agreement with a hospital 
or ensure all physicians performing surgery in the ASC have admitting 
privileges at a local hospital that meets CMS hospitalization 
requirements. All ASCs easily meet this requirement and have 
established a relationship with their local hospital and obtained an 
agreement as usual and customary practice for running an ASC with the 
exception of approximately twenty ASCs that have difficult 
relationships with their local hospitals. The savings would not be 
significant, however, it does affect the 20 ASCs by removing the 
requirement. The current information collection request for the ASC 
rules (OMB control number 0938-1071) does not address any potential 
burden associated with this requirement. We believe that having and 
maintaining written agreements is standard practice. Therefore, 
removing this requirement would not alter the current information 
collection burden for ASCs.

D. ICR Regarding ASC Medical Records (Sec.  416.47(b)(2))

    We propose to revise Sec.  416.47(b)(2) by adding the phrase ``(as 
applicable)'' to the significant medical history and results of 
physical examination requirement of documents that must be included in 
the medical record in order to conform to the changes that we are 
proposing to the mandatory medical history and physical examination 
requirement. There are no collection of information requirements 
associated with this proposed change because maintaining a medical 
record for each patient is a usual and customary practice in accordance 
with the implementing regulations of the PRA at 5 CFR 1320.3(b)(2).

E. ICRs Regarding ASC Patient Admission, Assessment and Discharge 
(Sec.  416.52(a)(1), (2), (3) and (4))

    At Sec.  416.52 we propose to replace the requirement that every 
patient have a comprehensive medical history and physical examination 
(H&P) within 30 days prior to surgery in an ASC with a requirement that 
allows the operating physician and ASC to determine which patients 
would require more extensive testing and assessment prior to surgery. 
The burden associated with this requirement would be the time and 
effort necessary to create new policies for when, and whether, to 
require some form of history and physical that would require pre-
operative examination and testing, and on what time schedule. The 
current information collection request for the ASC rules (OMB control 
number 0938-1071) does not account for any information collection 
related burden associated with the comprehensive H&P requirement. We 
assume that creating these policies (which could leave such decisions 
to the surgeon's discretion in most or all cases) would require 10 
hours of physician time, 10 hours of RN time, and 10 hours of clerical 
time, at the preceding hourly rates, for a total of 30 hours per 
facility. This would be a one-time cost of $3,440 per facility ([10 x 
$243] + [10 x $69] + [10 x $32]), and $19.1 million for all 5,557 
facilities. Therefore, this proposed requirement would increase the 
information collection related burden by $19.1 million and 166,710 
hours (30 hours x 5,557 facilities) on a one-time basis for all ASCs. 
The information collection request will be revised to account for the 
additional burden.

F. ICRs Regarding Hospice Aide and Homemaker Services (Sec.  418.76)

    At Sec.  418.76(a) we propose to defer to State training and 
competency requirements, where they exist, for hospice aides. The 
information collection request for the hospice requirements (OMB 
control number 0938-1067) is currently under review at OMB. It 
estimates that a hospice would spend 5 minutes per newly hired hospice 
aide to document verification that an aide meets the required training 
and competency requirements, for a total of 372 annual burden hours for 
all hospices at a cost of $11,540. This proposed change to the actual 
training and competency requirements would not alter the requirement to 
document the fact that a hospice aide meets one of the training and 
competency requirements set forth in the rule; therefore there would be 
no change to the existing collection of information estimates because 
the estimates relate to the unchanged documentation requirements rather 
than the actual training and competency requirements that would be 
revised by this proposed change.

G. ICRs Regarding Drugs and Biologicals, Medical Supplies, and Durable 
Medical Equipment (Sec.  418.106(a) and (e)(2)(i))

    At Sec.  418.106(a) we propose to remove the requirement that a 
hospice 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. The information collection request for the 
hospice requirements (OMB control number 0938-1067, currently under 
review at OMB) states that the burden associated with this requirement 
is the time necessary to document the results of this consultation in 
each patient's clinical record. In the information collection request 
we assumed that an average hospice would confer with a pharmacist, and 
that the pharmacist would document the results of his/her consultation. 
We estimated that it requires 5 minutes to document the initial review 
of a patient's drug and biologicals. Additionally, we estimated that it 
requires 5 minutes of the pharmacist's time to document a review of 
updates to the patient's drug profile. Based on a 17 day median length 
of service, we assumed that each patient would likely receive one 
update to their plans of care. At an average hourly rate of $115 for a 
pharmacist, we estimated that it would cost a hospice $19 per patient 
($115 x [5 minutes for initial + 5 minutes for 1 update]) and an annual 
cost of $6,764 ($19 x 356 patients). The total annual burden hours for 
all hospices was estimated to be 264,588 hours (1,587,527 patients x 
.1666 hour per patient), and the total annual burden cost for all 
hospices was estimated to be $30,163,013 ($19 per patient x 1,587,527 
patients). Therefore, removing the requirement that a hospice must 
ensure that the interdisciplinary group confers with an individual with 
education and training in drug management would result in a burden 
reduction of 264,588 hours and $30,163,013.
    We assume that, upon implementation of the proposed change to allow 
hospices to provide information regarding the safe maintenance and 
disposal of controlled drugs in a more user-friendly manner, hospices 
would develop understandable instructions in layperson terms to replace 
the copy of the policies and procedures that is currently provided. 
While the instructions could be created in any number of formats, such 
as a slide show, video, podcast, or pictograph, for purposes of our 
analysis we assume that hospices would create written instructions. We 
estimate that a hospice would use 1 hour of administrator time to 
develop a new form at $105 per hour. For all 4,602 hospices, the total 
initial cost would be $483,210.
    The information collection request will be revised and sent to OMB.

[[Page 47718]]

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

    At Sec.  418.112(f) we propose to allow hospices and long term care 
facilities the additional flexibility to negotiate the format and 
schedule for orienting long term care facility staff regarding certain 
hospice-specific information. A hospice and SNF/NF or ICF/IID must have 
a written agreement that specifies the provision of hospice services in 
the facility. The agreement must be signed by authorized 
representatives of the hospices and the SNF/NF or ICF/IID prior to the 
provision of hospice care services. The burden associated with this 
requirement is the time and effort necessary to develop, draft, sign, 
and maintain the written agreement. As stated in the hospice 
information collection request (OMB control number 0938-1067, currently 
under review at OMB), the use of this type of written agreement is a 
usual and customary business practice and the associated burden is 
exempt from the PRA under the implementing regulations at 5 CFR 
1320.3(b)(2). However, updating the written agreement to address this 
new requirement would not constitute a usual and customary business 
practice; therefore, we believe that a one-time burden to update the 
written agreement would be imposed by this change. For purposes of this 
analysis only, we estimate that each hospice would use 8 hours of 
administrator time to revise the existing written agreement. At a cost 
of $105 per hour for an administrator to complete this task, we 
estimate that the onetime cost per hospice would be $840. For all 
hospices the onetime cost would be $3,865,680 (4,602 hospices x $840) 
for 36,816 hours (4,602 hospices x 8 hours). The information collection 
request will be revised to account for this one time increase in burden 
and sent to OMB.

I. ICRs Regarding Hospital Quality Assessment and Performance 
Improvement (QAPI) Program (Sec.  482.21)

    We propose a new standard at Sec.  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.
    As stated in the information collection request for the hospital 
requirements (OMB control number 0938-0328), which is in the process of 
being reinstated, we estimate that the burden associated with updating 
and, in some instances, writing new hospital policies directly related 
to patient care would be an average of eight (8) hours annually for 
each member of hospital staff involved in the specific patient care 
policies addressed.
    Patient care policy development (and revision) by hospital medical 
staff is essential to patient health and safety because it provides the 
framework within which all patient care services are furnished. Thus, 
we have included the involvement of a physician at approximately $1,584 
annually (8 burden hours x $198), a QAPI nurse coordinator at $552 
annually (8 burden hours x $69), and a medical secretary at $272 
annually (8 burden hours x $34).
    We estimate the necessary policy changes needed to comply with the 
requirements proposed in this rule would cost $2,408 per year ($1,584 + 
$552 + $272) for each of the 424 hospital systems that would be 
eligible to do so and that would choose to exercise this option. 
Therefore, the total annual cost for all eligible hospital systems to 
meet these information collection requirements would be approximately 
$1 million.

J. ICRs Regarding Hospital Medical Staff, Medical Records Services, and 
Surgical Services (Sec. Sec.  482.22, 482.24, and 482.51)

    At Sec.  416.52 we propose to replace the requirement that every 
patient have a comprehensive H&P within 30 days prior to surgery in an 
ASC with a requirement that allows the operating physician and ASC to 
determine which patients would require more extensive testing and 
assessment prior to surgery. As discussed in ``Provisions of the 
Proposed Regulations,'' section II.D.2 of this proposed rule, there is 
a similar regulatory requirement for hospital outpatient surgery. Based 
on the substantial similarity between these two service settings, we 
propose, through the revisions to Sec. Sec.  482.22, 482.24, and 482.51 
discussed in section II.D.2, to provide an exception to these 
requirements for outpatient surgery in hospitals.
    As stated in the information collection request for the hospital 
requirements (OMB control number 0938-0328), which is in the process of 
being reinstated, we estimate that the burden associated with updating 
and, in some instances, writing new hospital policies directly related 
to patient care would be an average of eight (8) hours annually for 
each member of hospital staff involved in the specific patient care 
policies addressed.
    Patient care policy development (and revision) by hospital medical 
staff is essential to patient health and safety because it provides the 
framework within which all patient care services are furnished. Thus, 
we have included the involvement of a physician at approximately $1,584 
annually (8 burden hours x $198), a nurse coordinator at $552 annually 
(8 burden hours x $69), and a medical secretary at $272 annually (8 
burden hours x $34).
    We estimate that the necessary policy changes needed to comply with 
the requirements proposed in this rule would cost $2,408 per year 
($1,584 + $552 + $272) for each of the 5,031 hospitals that might 
choose to exercise this option. Therefore, the total annual cost for 
all hospitals to meet these information collection requirements would 
be approximately $12.1 million.

K. ICRs Regarding Hospital Medical Staff: Autopsies (Sec.  482.22)(d))

    We propose to remove the requirement at Sec.  482.22(d), which 
recommends 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. Since more detailed, 
specific requirements regarding medical-legal investigations and 
autopsies for

[[Page 47719]]

hospitals are covered by the individual State laws in which the 
hospital is located, there are no collection of information 
requirements associated with this proposed change.

L. ICRs Regarding Hospital Infection Control (Sec.  482.42)

    We propose a new standard at Sec.  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, were given due consideration; (3) had mechanisms in place to 
ensure that issues localized to particular hospitals were duly 
considered and addressed; and (4) has designated a qualified 
individual(s) with expertise in infection prevention and control at the 
hospital 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.
    As stated in the information collection request for the hospital 
requirements (OMB control number 0938-0328), which is in the process of 
being reinstated, we estimate that the burden associated with updating 
and, in some instances, writing new hospital policies directly related 
to patient care would be an average of eight (8) hours annually for 
each member of hospital staff involved in the specific patient care 
policies addressed.
    Patient care policy development (and revision) by hospital medical 
staff is essential to patient health and safety because it provides the 
framework within which all patient care services are furnished. Thus, 
we have included the involvement of a physician at approximately $1,584 
annually (8 burden hours x $198), an infection control nurse 
coordinator at $552 annually (8 burden hours x $69), and a medical 
secretary at $272 annually (8 burden hours x $34).
    We estimate the necessary policy changes needed to comply with the 
requirements proposed in this rule would cost $2,408 per year ($1,584 + 
$552 + $288) for each of the 424 hospital systems that would be 
eligible to do so and that would elect to exercise this option. 
Therefore, the total annual cost for all eligible hospital systems to 
meet these information collection requirements would be approximately 
$1 million.

M. ICRs Regarding Special Requirements for Hospital Providers of Long-
Term Care Services (``Swing-Beds'') (Sec.  482.58(b)(1), (4), (5), and 
(8), and Identical CAH requirements: Sec.  485.645(d)(1), (4), (5), and 
(8))

    At Sec. Sec.  482.58(b)(1) and 485.645(d)(1) (cross-referenced 
long-term care requirement at Sec.  483.10(f)(9)) we propose to remove 
the requirement for hospital and CAH swing-bed providers to provide the 
right for patients to choose to or refuse to perform services for the 
facility and if they so choose; (a) document in the resident's plan of 
care, (b) noting whether the services are voluntary or paid and (c) 
provide wages for the work being performed given the location quality, 
and quantity of work requiring comparable skills. We believe this 
requirement is unduly burdensome as we do not expect patient's 
receiving hospital or CAH swing-bed services have an average length of 
stay long enough to be positively impacted by providing services to the 
facility. We assume that each of the hospital swing-bed providers (478 
hospitals) and CAH swing-bed providers (1,246 CAHs) has an activities 
specialist employed at $40 per hour who would oversee the residents who 
have chosen to perform services for the facility, and document and 
update the plan of care accordingly. We believe that given the limited 
budget of most rural providers, services are being provided to the CAH 
on a voluntary basis and that these providers are not compensating 
patients for providing these services. The current regulatory burden 
for compliance with this requirement is approximately $29 million for 
all hospital and CAH swing-bed providers, or $16,821 per hospital or 
CAH swing-bed provider (1,724 hospital and CAH swing-bed providers x 
$40 an hour for an activities specialist x 8 hours per week x 52 weeks 
per year), which are the cost savings to the providers as a result of 
the removal of this requirement.
    At Sec.  482.58(b)(4) (and Sec.  485.645(d)(4)) (cross-referenced 
long-term care requirement at Sec.  483.24(c)), we propose to remove 
the requirement for hospital and CAH swing-bed providers to provide an 
ongoing activity program that is directed by a qualified therapeutic 
recreation specialist or an activities professional who meets certain 
requirements as listed at Sec.  483.24(c)(2). We assume that each of 
the hospital swing-bed providers (478 hospitals) and CAH swing-bed 
providers (1,246 CAHs) has an activities specialist employed at least 
part time at $40 per hour. CAHs are required to provide activity 
services by either a qualified individual who meet the requirements of 
Sec.  483.24(c)(2), or by an individual on the facility staff who is 
designated as the activities director and who serves in consultation 
with a therapeutic recreation specialist, occupational therapist, or 
other professional with experience or education in recreational 
therapy. For the purpose of this analysis, we assume that the cost of 
each would be the same due to the rural location of CAHs. The current 
regulatory burden for compliance with this requirement is based on the 
activities specialist organizing, overseeing, and scheduling the 
activity. The cost savings as a result of the removal of this 
requirement are approximately $72 million for all hospital and CAH 
swing-bed providers, or $41,800 per hospital or CAH swing-bed provider 
(1,724 hospital and CAH swing-bed providers x $40 an hour for an 
activities specialist x 1,040 hours per year) which are the cost 
savings to the providers. Our analysis assumes that the reduced 
staffing is largely for part-time work assignment (1,040 hours 
annually) at hospital and CAH swing-bed providers. It is likely that 
many of the actual persons holding these positions were full-time 
workers not devoted solely to recreational therapy, whose hours will 
simply be reassigned to other functions, with providers ultimately 
saving these full-time equivalent hours through ripple effects on an 
even wider range of staffing functions through turnover over time.
    We propose to remove the requirement at Sec. Sec.  482.58(b)(5) and 
485.645(d)(5) (cross-referenced long-

[[Page 47720]]

term care requirement at Sec.  483.70(p) for hospital and CAH swing-bed 
providers to employ a qualified social worker on a full-time basis if 
the facility has more than 120 beds. Given that this provision is not 
applicable to either provider type due to the regulatory requirements 
for each, it does not impose a burden upon hospitals and as such, its 
removal would not result in a savings of economic burden hours or 
dollars.
    At Sec. Sec.  482.58(b)(8) and 485.645(d)(8) (cross-referenced 
long-term care requirement at Sec.  483.55(a)(1)) we propose to remove 
the requirement for hospital and CAH swing-bed providers to assist in 
obtaining routine and 24-hour emergency dental care to its residents.
    Under the current CoPs, hospitals and CAHs are currently required 
to address the emergent dental care needs of their patients at Sec.  
482.12(f)(2) for hospitals, and at Sec.  485.618 (emergency services) 
for CAHs. As a result, we have calculated the burden associated with 
the provision of routine dental care for hospital and swing-bed 
patients. The American Dental Association recommends annual dental 
checkups for routine dental care for adults over 60 years of age. With 
an average length of stay in a hospital or CAH swing-bed of 1-2 weeks 
and an average daily census of 2 patients, we assume that 1 patient 
receiving swing-bed services will require routine dental services per 
month. While a dentist and dental hygienist provide the dental 
services, Medicare is billed for the provision of these services. The 
costs to the provider are related to the nursing activities associated 
with the patient receiving the dental services. The current regulatory 
burden for compliance with this requirement is approximately $2.9 
million for all hospital and CAH swing-bed providers, or $1,682 per 
hospital or CAH swing-bed provider (1,724 hospital and CAH swing-bed 
providers x $69 an hour for a RN x 24 hours per year), which are the 
cost savings to the providers as a result of the removal of this 
requirement. The information collection requests will be revised and 
sent to OMB for approval (OMB control number 0938-0328 for hospitals 
and 0938-1043 for CAHs).

N. ICRs Regarding Special Requirements for Psychiatric Hospitals (Sec.  
482.61(d))

    At Sec.  482.61(d) we propose to clarify the requirement allowing 
non-physician practitioners to document progress notes in accordance 
with State laws and scope of practice requirements. We believe this 
would apportion the burden associated with having MDs/DOs document 
their progress notes in psychiatric hospitals with non-physician 
practitioners and will decrease costs associated with this activity. In 
accordance with the information collection request for the hospital 
requirements, which includes the special requirements for psychiatric 
hospitals (OMB control number 0938-0328), no burden is associated with 
recordkeeping, as the documentation and maintenance of medical records 
is usual and customary. However, since we believe that clarification of 
the intent of the regulation is necessary and will result in non-
physician practitioners (specifically physician assistants, nurse 
practitioners, psychologists, and clinical nurse specialists) 
documenting the progress notes for patients receiving services in 
psychiatric hospitals, we are attributing ICR burden savings for this 
provision. For purposes of this analysis only, we estimate that MDs/DOs 
spend approximately 30 minutes documenting progress notes in 
psychiatric hospitals. We estimate that 33 percent of this time would 
be covered by non-physician practitioners. Of the 5,031 Medicare 
participating hospitals, 574 (or 11 percent) are psychiatric hospitals. 
According to AHA, there were 35,061,292 inpatient hospital stays in 
2015, and an estimated 11 percent of these stays were at psychiatric 
hospitals. The proposed change would result in a savings of $62.4 
million (3,856,742 psychiatric hospital stays x 0.5 hours of physician/
psychiatrist time x $98 per hourly wage difference between physicians/
psychiatrists ($198) and non-physician practitioners ($100, the average 
wage between nurse practitioners and physician assistants) x 33 percent 
of physician time spent writing progress notes covered by non-physician 
practitioners). This savings is equivalent to $108,647 per psychiatric 
hospital per year.

O. ICRs Regarding Special Requirement for Transplant Centers and 
Definitions (Sec. Sec.  482.68 and 482.70)

    We are proposing a nomenclature change at part 482 and the 
transplant center regulations at Sec. Sec.  482.68, 482.70, 482.72 
through 482.104, and at Sec.  488.61. Because 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, 
there are no collection of information requirements associated with 
this proposal.

P. ICRs Regarding Data Submission, Clinical Experience, and Outcome 
Requirements for Re-Approval of Transplant Centers (Sec.  482.82)

    Section 482.82 requires that, except as specified in Sec.  488.61, 
transplant centers must meet all the data submission, clinical 
experience, and outcome requirements to be re-approved for Medicare 
participation. Section 482.82(a) requires that no later than 90 days 
after the due date established by the OPTN, a transplant center must 
submit to the OPTN at least 95 percent of the required data submissions 
on all transplants (deceased and living donors) it has performed over 
the 3 year approval period. The required data submissions include, but 
are not limited to, submission of the appropriate OPTN forms for 
transplant candidate registration, transplant recipient registration 
and follow up, and living donor registration and follow up. 
Furthermore, Sec.  482.82(b) requires transplant centers to perform an 
average of 10 transplants per year during the prior 3 years and Sec.  
482.82(c) requires transplant centers to meet the outcome requirements 
for Medicare re-approval. The burden associated with this requirement 
would be the time it would take a transplant program to submit the 
required information. However, as required by Sec. Sec.  482.72 and 
482.45(b), a hospital in which a transplant program is located, must 
belong to the OPTN, and the OPTN requires that these hospitals submit 
this data to the OPTN. Therefore, we believe that the requirements 
under Sec.  482.82 do not impose an additional burden on transplant 
programs because all Medicare participating transplant programs are 
already submitting this information to the OPTN. Removing these 
requirements will have no additional collection of information burden 
on transplant programs. We describe additional life-saving benefits 
that result from the removal of this proposal in the subsequent RIA 
section.

Q. ICRs Regarding Special Procedures for Approval and Re-Approval of 
Organ Transplant Centers (Sec.  488.61(f) Through (h))

    Section 488.61(f) through (h) sets out the process for our 
consideration of a transplant center's mitigating factors in initial 
approval and re-approval surveys, certifications, and enforcement 
actions for transplant centers. The provisions also set out definitions 
and rules for transplant systems improvement agreements. We are 
proposing to remove the requirements at Sec.  488.61(f) through (h) for 
mitigating

[[Page 47721]]

factors and transplant systems improvement agreements for the re-
approval process for transplant centers. This change is complementary 
to the proposed removal of Sec.  482.82, described previously. The 
information collection request (OMB Control Number 0938-1069) does not 
account for any information collection related burden associated with 
the requirements in Sec.  488.61(f) through (h) for the re-approval 
process. Therefore, we estimate that the requirements under Sec.  
488.61(f) would require a transplant program to write and submit the 
initial formal notice of the program's intent to seek mitigating 
factors re-approval, and write and submit a request for consideration 
of mitigating factors (which would include all of the content listed in 
Sec.  488.61(f)(2)). We estimate that this would take a medical 
director, a transplant center senior administrator, and a hospital 
administrator approximately 5 hours, or 2 hours for the medical 
director and the transplant program senior administrator and 1 hour for 
the hospital administrator, to complete and submit these mitigating 
factors for re-approval, as described in Table 2.

   Table 2--Annual Burden Hours and Cost for Transplant Programs To Submit Mitigating Factors for Re-approval
----------------------------------------------------------------------------------------------------------------
                                                                                                    Total cost
                            Position                                Hourly wage   Hours required     estimate
----------------------------------------------------------------------------------------------------------------
Medical Director................................................            $194               2            $388
Transplant Program Senior Administrator.........................             105               2             210
Hospital Administrator..........................................             105               1             105
                                                                 -----------------------------------------------
    Totals......................................................  ..............               5             703
----------------------------------------------------------------------------------------------------------------

    In total, we estimate that an average of 14 programs would submit 
mitigating factors annually. Thus, for those 14 programs we estimate 
that it would require 70 burden hours (5 burden hours x 14 programs) at 
a cost of $9,842 ($703 x 14 programs). In the context of this proposed 
rule, removing this requirement would yield an estimated savings to 
transplant programs of 5 burden hours each and a total of 70 burden 
hours for all 14 programs, with a total cost savings of $9,842.
    In addition, we estimate that the transplant hospital in 
conjunction with the transplant program that is located in the 
hospital, would submit mitigating factors and then would also enter 
into systems improvement agreements, as described under Sec.  488.61(h) 
annually. This would require the hospital to enter into a binding 
agreement with CMS to allow the program additional time to achieve 
compliance with the CoPs. The agreement would require hospitals to 
complete certain tasks as listed and described in Sec.  488.61(h)(1), 
which include (but are not limited to): Patient notification about the 
degree and type of noncompliance by the program, an explanation of what 
the program improvement efforts mean for patients and financial 
assistance to defray the out-of-pocket costs of copayments and testing 
expenses for any wait-listed individual who wishes to be listed with 
another program, an external independent peer review team that conducts 
an onsite assessment of the program, an action plan that addresses 
systemic quality improvements and is updated after the onsite peer 
review, an onsite consultant who provides services for 8 days per month 
on average for the duration of the agreement, a comparative 
effectiveness analysis that compares policies, procedures, and 
protocols of the transplant program with those of other programs in 
areas of endeavor that are relevant to the center's current quality 
improvement needs, amongst other requirements listed in Sec.  
488.61(h)(1)(i) through (x). We estimate that this would take a medical 
director, a transplant program senior administrator, a hospital 
administrator, and an administrative assistant approximately 14 hours, 
or 4 hours for the medical director, transplant program senior 
administrator, and an administrative assistant, and 2 hours for the 
hospital administrator to complete these activities (including 
notifying patients about the degree of noncompliance by mail and 
organizing and completing the other tasks listed in Sec.  488.61(h)(1) 
as required by the terms in the systems improvement agreement), as 
described in Table 3.

 Table 3--Annual Burden Hours and Cost for Transplant Programs To Enter Into a Systems Improvement Agreement for
                                                   Re-Approval
----------------------------------------------------------------------------------------------------------------
                                                                                                    Total cost
                            Position                                Hourly wage   Hours required     estimate
----------------------------------------------------------------------------------------------------------------
Medical Director................................................            $194               4            $776
Transplant Program Senior Administrator.........................             105               4             420
Hospital Administrator..........................................             105               2             210
Administrative Assistant........................................              34               4             136
                                                                 -----------------------------------------------
    Totals......................................................  ..............              14           1,542
----------------------------------------------------------------------------------------------------------------

    In total, we estimate that an average of 14 programs will submit 
mitigating factors annually. Thus, for those 14 programs we estimate 
that it would require 196 burden hours (14 burden hours x 14 programs) 
at a cost of $21,588 ($1,542 x 14 transplant programs). In the context 
of this proposed rule, removing this requirement would yield an 
estimated savings to transplant programs of 14 burden hours each and a 
total of 196 burden hours for all 14 programs, with a total cost 
savings of $21,588.

R. ICRs Regarding HHA Home Health Aide Services (Sec.  484.80(h)(3))

    We propose to eliminate the requirement at Sec.  484.80(h)(3) that 
the HHA conduct a full competency evaluation of deficient home health

[[Page 47722]]

aides, and replace it with a requirement to retrain the aide regarding 
the identified deficient skill(s) and require the aide to complete a 
competency evaluation related only to those skills. The content of an 
aide competency examination does not have an associated collection of 
information requirement. Therefore, this proposed change would neither 
impose nor remove any collection of information burdens.

S. ICRs Regarding HHA Clinical Records (Sec.  484.110(e))

    We propose to remove the requirement at Sec.  484.110(e) related to 
providing a requested copy of information contained in the clinical 
record at the next home visit, while retaining the requirement to 
provide the record within 4 business days. As stated in the January 
2017 HHA CoP final rule (82 FR 4568 and 4575), we believe that 
providing such information to patients is a usual and customary 
practice that does not impose a burden upon HHAs and would not be 
subject to the PRA in accordance with the implementing regulations of 
the PRA at 5 CFR 1320.3(b)(2). As such, removing the ``next home 
visit'' timeframe requirement would not result in a savings of burden 
hours or dollars.

T. ICRs Regarding CORF Utilization Review Plan (Sec.  485.66)

    We propose to reduce the required frequency in which CORFs would be 
required to complete a ``utilization review plan'' from quarterly to 
annually. Changing from a quarterly implementation of the utilization 
review plan to an annual implementation would reduce the current 
documentation requirements (OMB control number 0938-1091) on CORFs by 
75 percent each year. For the purposes of our analysis, we estimate 
that it would take a CORF approximately 8 hours for administrative, 
clinical and clerical staff to review and evaluate the necessary and 
efficient use of services provided by the facility on a quarterly 
basis, for a total of 32 hours per year per CORF and 6,016 hours for 
all 188 CORFs. In a 1-year period, we estimate a savings of $1,644 per 
facility ($548 x 3 quarters), and a combined total savings of $309,072 
for all CORFs ($1644 x 188 CORFs). We will submit the revised 
information collection request to OMB for approval.

                                  Table 4--CORF--Hourly Wages and Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                    Hourly wage    Burden hours    Cost estimate
                            Position                                per CORF *       per CORF        per CORF
----------------------------------------------------------------------------------------------------------------
Administrator...................................................            $105               2            $210
Clerical Staff..................................................              32               2              64
Physical Therapist..............................................              84               2             168
Social Worker...................................................              53               2             106
                                                                 -----------------------------------------------
    Total.......................................................             274               8             548
----------------------------------------------------------------------------------------------------------------
* Includes 100% fringe benefits & overhead costs.

U. ICRs Regarding CAH Organizational Structure (Sec.  485.627(b)(1))

    As of May 2017, there were 1,343 CAHs that are certified by 
Medicare. Our proposed revision of the CAH disclosure requirements 
imposed on CAHs would remove the requirement for CAHs to disclose to 
CMS its owners, or those with a controlling interest in the CAH or in 
any subcontractor in which the CAH directly or indirectly has a 5 
percent or more ownership interest, in accordance with 42 CFR part 420, 
subpart C. While we estimate that these changes occur at 2 CAHs per 
year on average between all 1,343 CAHs, with the vast majority not 
experiencing any such changes throughout the lifetime of the CAH, each 
CAH is still required to review the duplicative documentation. In 
accordance with Medicare Program; Criteria and Standards for Evaluating 
Regional Durable Medical Equipment, Prosthetics, Orthotics and Supplies 
(DMEPOS); Final Rule and Request for Comments (57 FR 2790, June 18, 
1992), the burden associated with this requirement is 1-hour per 
facility. As a result, this proposal will save all CAHs an estimated 
$141,000 and will save each CAH $105 (1-burden hour for an 
administrator at $105 per hour x 1,343 CAHs). We will submit the 
revised information collection request to OMB for approval (OMB control 
number 0938-0328).

V. ICRs Regarding CAH Provision of Services (Sec.  485.635(a)(4))

    Section 485.635(a)(4) requires CAHs to conduct an annual review of 
all its policies and procedures. Based on feedback from stakeholders, 
the prescriptive annual schedule is burdensome or, in some situations, 
ineffective. Our proposed revision of the patient care policies 
requirements imposed on CAHs would reduce the frequency that is 
currently required for CAHs to perform a review of all their policies 
and procedures. We propose that a change from an annual review to a 
biennial review would reduce the burden on CAHs by half in a given 
period of time. For the purposes of our analysis, we estimate that it 
would take a CAH approximately 16 hours for administrative and clinical 
staff to review and make changes to policies and procedures annually. 
In a 2-year period, we estimate a savings of $1,956.10 per facility, 
and a combined total savings of $2.6 million for CAHs ($1,956.10 x 
1,343 CAHs).
    We estimate that the CAH staff time and associated costs would be 
assigned to a biennial review as shown in Table 5.

                                     Table 5--Hourly Wages and Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                    Hourly wage    Burden hours    Cost estimate
                            Position                                  per CAH         per CAH         per CAH
----------------------------------------------------------------------------------------------------------------
Administrator...................................................         $186.88               4         $747.52
Clerical staff..................................................           38.78               3          116.34
Registered Nurse................................................           69.40               3          208.20

[[Page 47723]]

 
Nurse practitioner..............................................          100.60               3          301.80
Physician.......................................................          194.08               3          582.24
                                                                 -----------------------------------------------
    Totals......................................................          589.74              16        1,956.10
----------------------------------------------------------------------------------------------------------------

W. ICRs Regarding Special Requirements for CAH Providers of Long-Term 
Care Services (``Swing-Beds'') (Sec.  485.645(d)(1), (4), (5) and (8))

    We have included the discussion of the ICRs regarding special 
requirements for CAH providers of long-term care services in the 
discussion of the ICRs regarding special requirements for hospital 
providers of long-term care services which can be found under section L 
of this part.

X. ICRs Regarding CMHCs (Sec.  485.914(d))

    Section 485.914(d)(1) requires each CMHC to update each client's 
comprehensive assessment via the CMHC interdisciplinary treatment team, 
in consultation with the client's primary health care provider (if 
any), no less frequently than every 30 days. We propose to modify the 
requirement at Sec.  485.914(d) to remove the 30-day assessment update 
time frame for those clients who do not receive PHP services. Instead 
of a fixed 30-day time frame, assessment updates would be completed 
when changes in the client's status, responses to treatment, or goal 
achievement have occurred, and in accordance with current standards of 
practice. The burden associated with these requirements is the time 
required to record an updated assessment. The current information 
collection request (OMB Control number 0938-1245) does not account for 
any information collected related to the burden associated with 
updating the comprehensive assessment requirement. While in the past we 
believed that this is considered usual and customary practice, recent 
comments from the CMHC provider community, submitted in response to 
CMS' solicitation for public comments pertaining to burden reduction 
suggestions, stated that it is not usual and customary to update 
assessments for non-PHP clients on a 30 day schedule as required by the 
CMHC regulations. The commenters stated that the 30 day requirement was 
overly burdensome, and suggested that the CMHC assessment update 
requirement should more closely align with the patient-oriented 
approach of other entities that govern CMHC operations. Upon further 
consideration, we agreed with the commenter that the 30 day requirement 
does, in fact, impose a burden and is not usual and customary practice. 
Therefore, removing this requirement would reduce information 
collection burden for CMHCs.
    Under the current 30-day time frame requirement, each client 
receives an updated assessment 12 times per year. We estimate that, in 
accordance with the proposed need-based assessment update requirements, 
each non-PHP client would receive 2 assessment updates in a year. 
Therefore, we estimate that this change would reduce the burden of 10 
assessments per client, per year.
    As of August 2017 there are 52 Medicare participating CMHCs serving 
3,122 Medicare beneficiaries and an estimated 2,080 non-Medicare 
clients, for an average of 100 clients per CMHC. In order to develop 
the estimated number of non-Medicare clients we divided the total 
number of Medicare beneficiaries who received partial hospitalization 
services by the total number of Medicare-participating CMHCs to 
establish the average number of Medicare beneficiaries per CMHC. This 
resulted in 60 beneficiaries per CMHC. We then assumed that, in order 
to comply with the 40 percent requirement (Sec.  485.918(b)(1)(v)), 
those 60 beneficiaries only accounted for 60 percent of an average 
CMHC's total patient population. This means that an average CMHC also 
treated another 40 clients who did not have Medicare as a payer source, 
for a total of 100 clients (Medicare + non-Medicare) in an average 
CMHC. Therefore, all CMHCs combined would have approximately 2,080 non-
PHP clients per year (40 per CMHC), and approximately 20,800 
assessments would be reduced nationwide per year (2,080 patients x 10 
assessments per patient). We estimate that documenting each assessment 
update requires 10 minutes of a CMHC clinician's time, for a total 
savings of 3,466 hours nationwide (1,666 hours x 20,800 assessment 
updates). At a cost of $7.33 for a mental health counselor to document 
each assessment, the total cost savings would be $152,464 ($7.33 x 
20,800 assessments).

Y. ICRs Regarding Portable X-Ray Services (Sec. Sec.  486.104(a) and 
486.106(a))

    We propose to revise the requirements for portable x-ray 
technologist personnel qualifications at Sec.  486.104 to align the 
current requirements at Sec.  486.104(a)(1), (2), (3), and (4) with 
those for hospital radiologic technologists at Sec.  482.26(c)(2) which 
are focused on the qualifications of the individual performing services 
as permitted by State law. Although changing the qualifications would 
require management time, with the associated cost of those hours, in 
order to revise the internal personnel descriptions and qualifications, 
we believe that this proposed change would impose no burden because 
maintaining internal personnel descriptions and qualifications is a 
standard business practice. Therefore, this burden would not be subject 
to the PRA in accordance with the implementing regulations of the PRA 
at 5 CFR 1320.3(b)(2).
    We propose to revise the requirements for portable x-ray orders at 
Sec.  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.
    This change would allow for portable x-ray services to be ordered 
in writing, by telephone, or by electronic methods. The change would 
also streamline the ordering process by avoiding the need to write two 
separate orders for the same study, one to meet the Medicare payment 
requirements in accordance with Sec.  410.32 and its associated Manual 
guidance, and another to meet the content requirements of the 
regulation set forth at Sec.  486.106. We believe the proposed change 
would allow for additional ordering flexibility to streamline ordering 
practices. In the information collection request (OMB control number 
0938-0338) we estimate

[[Page 47724]]

that the current order requirements would impose the following burdens:
     3 minutes to write an order x 3,986,000 portable x-rays 
exams ordered = 199,300 hours x $69/hour for a nurse = $13,751,700.
     $1 for printing and faxing verbal orders to physician 
offices for signature x 2,500,000 verbal orders = $2,500,000.
     2,000,000 follow-up calls regarding the status of faxes x 
10 minutes of time for clerical staff (5 minutes for portable x-ray 
clerical staff + 5 minutes for ordering physician clerical staff) = 
333,333 hours x $32/hour = $10,666,656.
    All of these burdens would be eliminated by revising the current 
ordering standards. Therefore, we estimate a proposed information 
collection savings of $26,918,356 from this proposed change.

Z. ICRs Regarding RHC and FQHC Provision of Services (Sec.  
491.9(b)(4))

    There are currently more than 4,100 RHCs and approximately 1,400 
FQHC organizations furnishing services at approximately 12,000 or more 
total locations. Many FQHC organizations have multiple delivery sites, 
so to be as accurate as possible, our burden reduction calculations are 
based on the most recent data available, which shows that as of May 
2017, there were 4,160 RHCs and 7,874 FQHC delivery sites. All CMS-
certified sites are subject to our requirements and we are therefore 
utilizing the total number of current sites in our burden reduction 
calculations.
    We propose to revise Sec.  491.9(b)(4) to reduce the number of 
times that RHCs and FQHCs perform a review of all their policies and 
procedures. Changing from an annual review to a review every other year 
would reduce the burden on RHCs and FQHCs by half in a given period of 
time. In the currently approved information collection request (OMB 
control number 0938-0334), we estimate that it would take a RHC or FQHC 
approximately 4 hours for clinical staff to review and make changes to 
policies and procedures annually, for a total of 48,136 hours for all 
12,034 RHC and FQHC locations. In a 2-year period, RHCs and FQHCs would 
use 96,272 total hours to comply with the requirements to annually 
review all of their policies and procedures. Under the proposed change 
to a review every other year, we estimate that in a 2-year period, it 
will take a total of 48,136 hours, for a savings of 48,136 hours per 
year. We estimate a savings of $592 per facility (see Table 6) for a 
combined total savings of $7.1 million for 12,034 RHCs or FQHCs ($592 x 
12,034 RHCs and FQHCs). We will submit a revised information collection 
request to OMB for approval.

                                     Table 6--Hourly Wages and Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                    Hourly wage
                                                                   per  RHC/FQHC
                            Position                              (Includes 100%   Burden hours    Cost estimate
                                                                      benefit      per  RHC/FQHC   per RHC/FQHC
                                                                     package)
----------------------------------------------------------------------------------------------------------------
Physician.......................................................            $198               2            $396
Mid-Level Provider (PA or NP)...................................              98               2             196
                                                                 -----------------------------------------------
    Total.......................................................             296               4             592
----------------------------------------------------------------------------------------------------------------

AA. ICRs Regarding RHC and FQHC Program Evaluation (Sec.  491.11(a))

    We propose to revise Sec.  491.11(a) to reduce the number of times 
that RHCs and FQHCs carry out or arrange for an annual evaluation of 
the total program. Changing from an annual evaluation to an evaluation 
every other year would reduce the burden on RHCs and FQHCs by half in a 
given period of time. In the currently approved information collection 
request (OMB control number 0938-0334), we estimate that it would take 
a RHC or FQHC approximately 6 hours for administrative and clinical 
staff to perform an evaluation of its total program annually for a 
total of 72,204 hours for all 12,034 RHC and FQHC locations. In a 2-
year period, RHCs and FQHCs would use 144,408 total hours to comply 
with the requirement for an evaluation of the total program. Under the 
proposed change to evaluate the total program every other year, we 
estimate a hourly savings of 72,204 total hours and a cost savings of 
$802 per facility (see Table 7), for a combined total savings of $9.7 
million for 12,034 RHCs or FQHCs ($802 x 12,034 RHC and FQHC 
locations).

                                     Table 7--Hourly Wages and Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                    Hourly wage
                                                                   per  RHC/FQHC
                            Position                              (Includes 100%   Burden hours    Cost estimate
                                                                      benefit      per RHC/FQHC    per  RHC/FQHC
                                                                     package)
----------------------------------------------------------------------------------------------------------------
Administrator/Health Services Manager...........................            $105               2            $210
Physician.......................................................             198               2             396
Mid-Level Provider (PA or NP)...................................              98               2          196.00
                                                                 -----------------------------------------------
    Total.......................................................             401               6             802
----------------------------------------------------------------------------------------------------------------


[[Page 47725]]

BB. ICRs Regarding Emergency Preparedness for Providers and Suppliers

1. Review of the Emergency Preparedness Program
    At Sec.  482.15(a), (b), (c), and (d) for hospitals and parallel 
regulatory citations for other facilities, we propose to allow 
providers to review their program at least every 2 years. As of May 
2017, there were approximately 74,246 total facilities. All are 
required to review their emergency preparedness program annually, which 
includes a review of their emergency plan, policies and procedures, 
communication plan, and training and testing program.
    For our analysis, we estimate that reducing this requirement from 
annually to biennially would reduce compliance costs related to review 
of the emergency plan by 50 percent. The methodology used for our cost 
estimate analysis generally mirrors the methodology used for the annual 
review of the emergency plan Emergency Preparedness final rule (81 FR 
63930) with a 50 percent reduction in the cost estimate calculation; 
however, after receiving additional feedback from stakeholders, we have 
determined that we underestimated the amount of time it would take to 
review the emergency plan. As a result, we have presented current 
burden hours associated with reviewing the emergency plan that reflects 
the increased associated burden hours relative to the information 
collection request for this provision (OMB control number 0938-1325). 
As in the Emergency Preparedness final rule (81 FR 63930), we assume 
that the individuals involved in the review of the emergency plan 
include an administrator, director of nursing, a RN, a physician, a 
social worker, a counselor, and an office manager, depending on the 
facility type. Based on May 2016 BLS salary data, we calculated the 
hourly mean wage for each position for this requirement identified in 
the Emergency Preparedness final rule (81 FR 63930).
    We estimate that the proposed change will accrue a total annual 
cost savings of $94,312,719 and 187 burden hours saved. We list a 
detailed calculation for each facility below, based on facility numbers 
available as of May 2017:
     RNHCIs: Combined total savings of $9,540 for 18 RNHCIs ((8 
burden hours for an administrator at $105 plus 5 burden hours for a 
director of nursing at $44 per hour) x 18 RNHCIs x 50 percent).
     ASCs: Combined total savings of $6,134,928 for 5,557 ASCs 
((8 burden hours for an administrator at $108 per hour plus 4 burden 
hours for a physician at $198 per hour plus 8 burden hours for a 
quality improvement RN at $69 per hour) x 5,557 ASCs x 50 percent).
     Hospices: Combined total savings of $5,781,832 for 4,489 
hospice facilities ((8 burden hours for an administrator at an hourly 
wage of $105 per hour plus 4 burden hours for a physician at $198 per 
hour plus 4 burden hours for a counselor at $44 per hour plus 4 burden 
hours for a social worker at $54 per hour plus 8 burden hours for a RN 
at $69 per hour) x 4,489 hospices x 50 percent).
     PRTFs: Combined total savings of $556,512 for 374 PRTFs 
((8 burden hours for an administrator $105 per our plus 8 burden hours 
for a physician at $198 per hour plus 8 burden hours for a RN at $69 
per hour) x 374 PRTFs x 50 percent).
     PACE: Combined total savings of $226,476 for 233 PACE 
organizations ((8 burden hours for an administrator at $105 per hour 
plus 8 burden hours for a home care coordinator at $69 per hour plus 8 
burden hours for a RN at $69 per hour) x 233 PACE organizations x 50 
percent).
     Hospitals: Combined total savings of $11,933,532 for 5,031 
hospitals ((8 burden hours for an administrator at $108 per hour plus 8 
burden hours for a physician at $198 per hour plus 8 burden hours for a 
risk management director at $105 per hour plus 8 burden hours for a 
quality assurance nurse at $69 per hour plus 8 burden hours for a 
facility director at $96 per hour plus 4 burden hours for a medical 
secretary at $34 per hour) x 5,031 hospitals x 50 percent).
     LTCF: Combined total savings of $25,562,016 for 15,663 
LTCF facilities ((8 burden hours for an administrator at $105 per hour 
plus 8 burden hours for a physician at $198 per hour plus 8 burden 
hours for a director of nursing at $105 per hour) x 15,663 LTCFs x 50 
percent).
     ICF/IID: Combined total savings $3,402,126 for 6,097 ICF/
IIDs ((8 burden hours for an administrator at $105 per hour plus 4 
burden hours for a RN $69 per hour) x 6,097 ICF/IIDs x 50 percent).
     HHA: Combined total savings of $16,259,712 for 12,624 HHAs 
((8 burden hours for an administrator at $105 per hour plus 8 burden 
hours for a nursing director at $105 per hour plus 8 burden hours for a 
director of rehab at $84 per hour plus 4 burden hours for an office 
manager at $56 per hour) x 12,624 HHAs x 50 percent).
     CORF: Combined total savings of $142,128 for 188 CORFs ((8 
burden hours for an administrator at $105 per hour plus 8 burden hours 
for a physical therapist at $84 per hour) x 188 CORFs x 50 percent).
     CAH: Combined total savings of $1,643,832 for 1,343 CAHs 
((8 burden hours for an administrator at $105 per hour plus 8 burden 
hours for a director of nursing at $105 per hour plus 8 burden hours 
for a facility director at $96 per hour) x 1,343 CAHs x 50 percent).
     Organizations: Combined total savings of $1,220,688 for 
2,076 Organizations ((8 burden hours for an administrator at $105 per 
hour plus 4 burden hours for a physical therapist at $84 per hour) x 
2,076 Organizations x 50 percent).
     CMHCs: Combined total savings of $146,832 for 161 CMHCs 
((8 burden hours for an administrator at $105 per hour plus 8 burden 
hours for a RN at $69 per hour plus 8 burden hours for a social worker 
at $54 per hour) x 161 CMHCs x 50 percent).
     OPOs: Combined total savings of $119,016 for 58 OPOs ((8 
burden hours for an OPO director at $105 per hour plus 8 burden hours 
for a physician at $198 per hour plus 8 burden hours for a QAPI 
director at $105 per hour plus 8 burden hours for an organ procurement 
coordinator at $105 per hour) x 58 OPOs x 50 percent).
     RHC/FQHC: Combined total savings of $9,916,016 ((8 burden 
hours for an administrator at $105 per hour plus 8 burden hours for a 
nurse practitioner/physician assistant at $101 per hour) x 4,160 RHCs x 
50 percent) $3,427,840 + ((8 burden hours for an administrator at $105 
per hour plus 8 burden hours for a nurse practitioner/physician 
assistant at $101 per hour x 7,874 FQHCs x 50 percent) $6,488,176).
     ESRD Facilities: Combined total savings of $11,064,392 for 
6,898 dialysis facilities ((8 burden hours for an administrator at $105 
per hour plus 8 burden hour for a medical director/physician at $198 
per hour plus 8 burden hours for a nurse manager at $105) x 6,898 
dialysis facilities x 50 percent) as shown in Table 8.

[[Page 47726]]



 Table 8--Cost Savings for Annual Review of Emergency Preparedness Plan
------------------------------------------------------------------------
                                  Cost savings
       Provider/supplier          per provider/   Combined total savings
                                    supplier
------------------------------------------------------------------------
RNHCIs.........................            $530  $9,540 for 18 RNHCIs.
ASCs...........................           1,104  $6,134,928 for 5,557
                                                  ASCs.
Hospices.......................           1,288  $5,781,832 for 4,489
                                                  hospice facilities
                                                  both inpatient and
                                                  freestanding/home
                                                  based.
PRTFs..........................           1,488  $556,512 for 374 PRTFs.
PACEs..........................             972  $226,476 for 233 PACEs.
Hospitals......................           2,372  $11,933,532 for 5,031
                                                  hospitals.
LTCFs..........................           1,632  $25,562,016 for 15,663
                                                  LTCFs.
ICFs/IIDs......................             558  $3,402,126 for 6,097
                                                  ICF/IIDs.
HHAs...........................           1,288  $16,259,712 for 12,624
                                                  HHAs.
CORFs..........................             756  $142,128 for 188 CORFs.
CAHs...........................           1,224  $1,643,832 for 1,343
                                                  CAHs.
Organizations..................             588  $1,220,688 for 2,076
                                                  Organizations.
CMHCs..........................             912  $146,832 for 161 CMHCs.
OPOs...........................           2,052  $119,016 for 58 OPOs.
RHCs/FQHCs.....................             824  $9,916,016 for RHCs and
                                                  FQHCs ($3,427,840 for
                                                  4,160 RHCs and
                                                  $6,488,176 for 7,874
                                                  FQHCs).
ESRD Facilities................          1,6332  $11,257,536 for 6,898
                                                  dialysis facilities.
------------------------------------------------------------------------

2. Contents of the Emergency Plan
    At Sec.  482.15(a)(4) for hospitals, and other parallel citations 
for the facilities mentioned in section II.J.2 of this proposed rule, 
we propose to eliminate the requirement that facilities document 
efforts to contact local, tribal, regional, State, and Federal 
emergency preparedness officials and that facilities document 
participation in collaborative and cooperative planning efforts. We 
estimate that an administrator, or in the case of a hospital a 
community relations manager, a program director for a PACE, or a QAPI 
director for OPOs, would take 1 hour to document efforts to contact 
local, tribal, regional, State and Federal emergency preparedness 
officials and, when applicable, document the facility's participation 
in collaborative and cooperative planning efforts. We note that the 
Joint Commission (TJC)-accredited ASCs, TJC-accredited CAHs, and TJC-
accredited hospitals have emergency preparedness requirements for 
developing an emergency preparedness plan that are comparable to the 
current emergency preparedness CoPs (81 FR 63937, 63954, and 63978 
through 63979). Utilizing the same assumptions we used in the Emergency 
Preparedness final rule (81 FR 63937, 63954, and 63978 through 63979), 
we estimate that cost savings will accumulate from non-TJC accredited 
ASC, CAHs, and hospitals, since TJC-accredited ASCs, CAHs and hospitals 
are already required by the TJC to develop emergency preparedness 
plans. As a result, these facilities are excluded from the analysis 
given the requirements of their accreditation organization standards. 
Based on May 2016 BLS salary data, we calculate an hourly mean wage of 
$105 for an administrator, a PACE Program Director, or QAPI director 
and a cost savings of $105 per facility for RNHCIs, non-TJC accredited 
ASCs, hospices (both inpatient and freestanding), PRTFs, PACEs, LTCFs, 
ICF/IIDs, HHAs, CORFs, non-TJC accredited CAHs, Organizations, CMHCs, 
OPOs, RHC/FQHCs, and dialysis facilities ($105 hourly mean wage x 1 
burden hour). For non-TJC accredited hospitals, we estimate an hourly 
mean wage of $114 for a community relations manager, and a $114 cost 
per facility ($114 x 1 hour). Therefore, we estimate the following for 
each facility affected by the proposed change, for a total savings of 
$7,179,117 and 18 burden hours. We list a summary of the calculation 
for savings accrued by removing this requirement for each facility in 
Table 9, based on facility numbers available as of May 2017.

 Table 9--Cost Savings: Documentation of the Facility's Participation in
             Collaborative and Cooperative Planning Efforts
------------------------------------------------------------------------
                                  Cost savings
       Provider/supplier          per provider/   Combined total savings
                                    supplier
------------------------------------------------------------------------
RNHCIs.........................            $105  $1,890 for 18 RNHCIs.
ASCs (Non-TJC accredited)......             105  $522,375 for 4,975 non-
                                                  TJC accredited ASCs.
Hospices.......................             105  $471,345 for 4,489
                                                  hospice facilities
                                                  both inpatient and
                                                  freestanding/home
                                                  based.
PRTFs..........................             105  $39,270 for 374 PRTFs.
PACEs..........................             105  $24,465 for 233 PACEs.
Hospitals (Non-TJC accredited).             114  $157,662 for 1,383 non-
                                                  TJC accredited
                                                  hospitals.
LTCFs..........................             105  $1,644,615 for 15,663
                                                  LTCFs.
ICFs/IIDs......................             105  $640,185 for 6,097 ICF/
                                                  IIDs.
HHAs...........................             105  $1,325,520 for 12,624
                                                  HHAs.
CORFs..........................             105  $19,740 for 188 CORFs.
CAHs (Non-TJC accredited)......             105  $103,215 for 983 non-
                                                  TJC accredited CAHs.
Organizations..................             105  $217,980 for 2,076
                                                  Organizations.
CMHCs..........................             105  $16,905 for 161 CMHCs.
OPOs...........................             105  6,090 for 58 OPOs.
RHCs/FQHCs.....................             105  $1,263,570 for RHCs and
                                                  FQHCs ($436,800 for
                                                  4,160 RHCs and
                                                  $826,770 for 7,874
                                                  FQHCs).

[[Page 47727]]

 
ESRD Facilities................             105  $724,290 for 6,898
                                                  dialysis facilities.
------------------------------------------------------------------------

3. Training
    At Sec.  482.15(d)(1)(ii) for hospitals, and other parallel 
citations for other facilities mentioned in section II.J.2 of this 
proposed rule, we propose to require that facilities provide training 
biennially, or every 2 years, after facilities conduct initial training 
on their emergency program. In addition, we propose to require 
additional training when the emergency plan is significantly updated. 
We believe that the annual training requirement is too prescriptive as 
annual may not always be necessary. We propose to maintain the 
requirement that providers and suppliers develop a well-organized, 
effective training program that includes initial training for new and 
existing staff in emergency preparedness policies and procedures and 
would require training when the emergency plan is significantly 
updated. Facilities would have the flexibility to determine what is 
considered a significant update to the emergency plan.
    For our analysis, we estimate that reducing this requirement from 
annually to biennially will reduce compliance costs related to 
providing emergency preparedness training by 50 percent. The 
methodology used for our cost estimate analysis mirrors the methodology 
used for the annual training requirement in the Emergency Preparedness 
final rule (81 FR 63930) with a 50 percent reduction in the cost 
estimate calculation. As in the Emergency Preparedness final rule (81 
FR 63930), we assume that the individuals involved in the development 
and provision of training include an administrator, director of 
nursing, a RN, and an office manager, depending on the facility type. 
Providers and suppliers are expected to provide initial training in 
emergency preparedness policies and procedures to all new and existing 
staff, individuals providing services under arrangement, and 
volunteers, consistent with their expected roles, and maintain 
documentation of the training. Based on May 2016 BLS salary data, we 
calculated the hourly mean wage for each position for this requirement 
identified in the Emergency Preparedness final rule (81 FR 63930). We 
estimate that the proposed change will accrue a total annual cost 
savings of $33,267,864 and 111 burden hours. We list a detailed 
calculation for each facility below, based on facility numbers 
available as of May 2017 with a summary of these calculations provided 
in Table 10:
     RNHCIs: Combined total savings of $3,870 for 18 RNHCIs ((2 
burden hours for an administrator at $105 plus 5 burden hours for a 
director of nursing at $44 per hour) x 18 RNHCIs x 50 percent).
     ASCs: Combined total savings of $1,258660 for 5,557 ASCs 
((1 burden hour for an administrator at $108 per hour plus 5 burden 
hours for a quality improvement RN at $69 per hour) x 5,557 ASCs x 50 
percent).
     Hospices: Combined total savings of $929,223 for 4,489 
hospice facilities (6 burden hours for a RN at $69 per hour x 4,489 
hospices x 50 percent).
     PRTFs: Combined total savings of $129,030 for 374 PRTFs 
(10 burden hours for a RN at $69 per hour x 374 PRTFs x 50 percent).
     PACE: Combined total savings of $96,462 for 233 PACE 
organizations (3 burden hours for a home care coordinator at $69 per 
hour plus 9 burden hours for a RN at $69 per hour x 233 PACE 
organizations x 50 percent).
     Hospitals: As we stated in the Emergency Preparedness 
final rule (81 FR 63958), TJC-accredited hospitals are required to 
train their staff for their assigned roles during emergencies (CAMH, 
Standard EC.4.16, Eps 1-2, p. EC-13e). In addition, the TJC-accredited 
hospitals also must provide on-going training to their staff, including 
training on specific job-related safety (CAMH, Standard HR-2.30, EP 4, 
CAMH Refreshed Core, January 2008, p. HR-11), and we expect that 
emergency preparedness is part of such on-going training. As a result, 
we estimate a combined total savings of $2,015,031 for 1,383 non-TJC 
accredited hospitals (2 burden hours for an administrator at $108 per 
hour plus 6 burden hours for a risk management director at $105 per 
hour plus 28 hours for a healthcare trainer (RN) at $69 per hour plus 4 
burden hours for a medical secretary at $34 per hour x 1,383 hospitals 
x 50 percent).
     LTCF: Combined total savings of $8,223,075 for 15,663 
LTCFs (2 burden hours for an administrator at $105 per hour plus 8 
burden hours for a director of nursing at $105 per hour x 15,663 LTCFs 
x 50 percent).
     ICF/IID: Combined total savings $1,691,918 for 6,097 ICF/
IIDs (2 burden hours for an administrator at $105 per hour plus 5 
burden hours for a RN $69 per hour x 6,097 ICF/IIDs x 50 percent).
     HHA: Combined total savings of $7,902,624 for 12,624 HHAs 
(2 burden hours for an administrator at $105 per hour plus 2 burden 
hours for a nursing director at $105 per hour plus 2 burden hours for a 
director of rehab at $84 per hour plus 2 burden hours for an office 
manager at $56 per hour plus 8 burden hours for a director of training 
at $69 x 12,624 HHAs x 50 percent).
     CORF: Combined total savings of $73,038 for 188 CORFs (5 
burden hours for an administrator at $105 per hour plus 3 burden hours 
for a physical therapist at $84 per hour x 188 CORFs x 50 percent).
     CAH: Combined total savings of $968,974 for 1,343 CAHs (2 
burden hours for an administrator at $105 per hour plus 9 burden hours 
for a director of nursing at $105 per hour plus 3 burden hours for a 
facility director at $96 per hour x 1,343 CAHs x 50 percent).
     Organizations: Combined total savings of $828,324 for 
2,076 Organizations (6 burden hours for an administrator at $105 per 
hour plus 2 burden hours for a physical therapist at $84 per hour x 
2,076 Organizations x 50 percent).
     CMHCs: Combined total savings of $55,545 for 161 CMHCs (10 
burden hours for a psychiatric RN at $69 per hour x 161 CMHCs x 50 
percent).
     OPOs: Combined total savings of $111,012 for 58 OPOs (2 
burden hours for a director at $114 per hour plus 2 burden hours for a 
medical director/physician at $198 per hour plus 12 burden hours for a 
QAPI director at $105 per hour plus 8 hours for an organ procurement 
coordinator at $105 per hour plus 16 burden hours for an education 
coordinator at $69 per hour x 58 OPOs x 50 percent).
     RHC/FQHC: Combined total savings of $6,125,306 ((2 burden 
hours for an

[[Page 47728]]

administrator at $105 per hour plus 8 burden hours for a nurse 
practitioner/physician assistant at $101 per hour x 4,160 RHCs x 50 
percent) $2,117,440 + (2 burden hours for an administrator at $105 per 
hour plus 8 burden hours for a nurse practitioner/physician assistant 
at $101 per hour x 7,874 FQHCs x 50 percent) $4,007,866).
     ESRD Facilities: Combined total savings of $2,855,772 for 
6,898 dialysis facilities (3 burden hours for an administrator at $105 
per hour plus 1 burden hour for a medical director/physician at $198 
per hour plus 3 burden hours for a nurse manager at $105 x 6,898 
dialysis facilities x 50 percent).

                                        Table 10--Cost Savings: Training
----------------------------------------------------------------------------------------------------------------
                                                 Cost savings
               Provider/supplier                 per provider/               Combined total savings
                                                   supplier
----------------------------------------------------------------------------------------------------------------
RNHCIs........................................            $215  $3,870 for 18 RNHCIs.
ASCs..........................................             226  $1,258,660 for 5,557 ASCs.
Hospices......................................             207  $929,223 for 4,489 hospice facilities both
                                                                 inpatient and freestanding/home based.
PRTFs.........................................             345  $129,030 for 374 PRTFs.
PACEs.........................................             414  $96,462 for 233 PACE organizations.
Hospitals (Non-TJC accredited)................           1,457  $2,015,031 for 1,383 non-TJC accredited
                                                                 hospitals.
LTCFs.........................................             525  $8,223,075 for 15,663 LTCFs.
ICFs/IIDs.....................................             278  $1,691,918 for 6,097 ICF/IIDs.
HHAs..........................................             626  $ 7,902,624 for 12,624 HHAs.
CORFs.........................................             389  $73,038 for 188 CORFs.
Organizations.................................             399  $828,324 for 2,076 Organizations.
CAHs..........................................             721  $968,974 for 1,343 CAHs.
CMHCs.........................................             345  $55,545 for 161 CMHCs.
OPOs..........................................           1,914  $1111,012 for 58 OPOs.
RHCs/FQHCs....................................             509  $6,125,306 for RHCs and FQHCs ($2,117,440 for
                                                                 4,160 RHCs and $4,007,866 for 7,874 FQHCs).
ESRD Facilities...............................             414  $2,855,772 for 6,898 dialysis facilities.
----------------------------------------------------------------------------------------------------------------

4. Testing
    Finally, at Sec.  482.15(d)(2), we propose to require that 
providers of inpatient services mentioned in section II.J.2 of this 
proposed rule conduct two testing exercises annually, one of which may 
be an exercise of their choice that must be either a community-based 
full-scale exercise (if available), an individual facility-based 
functional exercise, a drill, a tabletop exercise or workshop that 
includes a group discussion led by a facilitator. We estimate that 
revising this requirement to include additional options for the types 
testing exercises that may be conducted for one of the two annually 
required exercises will provide greater flexibility for these 
providers. Given that these providers are currently required to conduct 
two testing exercises annually, and because they may choose to conduct 
the same types of testing exercises, we do not anticipate that this 
requirement will impose a burden upon providers of inpatient services 
and as such, this revision would not result in a savings of burden 
hours or dollars.
    We propose to require that providers of outpatient services 
mentioned in section II.J.2 of this proposed rule conduct one testing 
exercise annually which must be either a community-based full-scale 
exercise (if available) or an individual facility-based functional 
exercise every other year, and in the opposite years, may be either 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.
    For our analysis, we estimate that reducing this requirement from 
biannually to annually for outpatient providers will reduce compliance 
costs related to conducting emergency preparedness testing by 50 
percent. The methodology used for our cost estimate analysis mirrors 
the methodology used for the biannual testing requirement in the 
Emergency Preparedness final rule (81 FR 63930) with a 50 percent 
reduction in the cost estimate calculation. As in the Emergency 
Preparedness final rule (81 FR 63930), we will assume that the same 
individuals involved with developing training would typically also 
develop the scenarios, materials, as well as any accompanying 
documentation associated with testing exercises. Based on May 2016 BLS 
salary data, we calculated the hourly mean wage for each position for 
this requirement identified in the Emergency Preparedness final rule 
(81 FR 63930) and decreased the cost by 50 percent due to the 50 
percent reduction in the frequency requirement.
    We estimate that the proposed change will accrue a total annual 
cost savings of $9,117,425 and 25 burden hours. We list a detailed 
calculation for each facility below, based on facility numbers 
available as of May 2017 with a summary of these calculations provided 
in Table 11:
     ASCs: Combined total savings of $1,066,944 for 5,557 ASCs 
((1 burden hour for an administrator at $108 per hour plus 4 burden 
hours for a quality improvement RN at $69 per hour) x 5,557 ASCs x 50 
percent).
     Freestanding/home-based hospices: Combined total savings 
of $557,520 for 4,040 hospice facilities (4 burden hours for a RN at 
$69 per hour x 4,040 hospices x 50 percent).
     PACE: Combined total savings of $40,193 for 233 PACE 
organizations (4 burden hours for a home care coordinator at $69 per 
hour plus 1 burden hours for a RN at $69 per hour x 233 PACE 
organizations x 50 percent).
     HHA: Combined total savings of $3,970,248 for 12,624 HHAs 
(1 burden hour for an administrator at $105 per hour plus 3 burden 
hours for a nursing director at $105 per hour plus 1 burden hours for a 
director of rehab at $84 per hour plus 1 burden hour for an office 
manager at $56 per hour plus 1 burden hours for a director of training 
at $69 x 12,624 HHAs x 50 percent).
     CORF: Combined total savings of $55,272 for 188 CORFs (4 
burden hours for an administrator at $105 per hour plus 2 burden hours 
for a physical therapist at $84 per hour x 188 CORFs x 50 percent).
     Organizations: Combined total savings of $305,172 for 
2,076 organizations (2 burden hours for an administrator at $105 per 
hour plus 1

[[Page 47729]]

burden hour for a physical therapist at $84 per hour x 2,076 
organizations x 50 percent).
     CMHCs: Combined total savings of $22,218 for 161 CMHCs (4 
burden hours for a psychiatric RN at $69 per hour x 161 CMHCs x 50 
percent).
     OPOs: Combined total savings of $12,673 for 58 OPOs (3 
burden hours for a QAPI director at $105 per hour plus 2 burden hours 
for an education coordinator at $69 per hour x 58 OPOs x 50 percent).
     RHC/FQHC: Combined total savings of $3,086,721 ((2 burden 
hours for an administrator at $105 per hour plus 3 burden hours for a 
nurse practitioner/physician assistant at $101 per hour x 4,160 RHCs x 
50 percent) + (2 burden hours for an administrator at $105 per hour 
plus 3 burden hours for a nurse practitioner/physician assistant at 
$101 per hour x 7,874 FQHCs x 50 percent)).
     ESRD: As identified in the Emergency Preparedness final 
rule (81 FR 64006), the current CFCs already require dialysis 
facilities to evaluate their emergency preparedness plan at least 
annually (Sec.  494.60(d)(4)(ii)); thus, we expect that all dialysis 
facilities are already conducting some type of tests to evaluate their 
emergency preparedness plans. As a result, ESRDs are not included in 
the burden calculation.

                                         Table 11--Cost Savings: Testing
----------------------------------------------------------------------------------------------------------------
                                                 Cost savings
               Provider/supplier                 per provider/               Combined total savings
                                                   supplier
----------------------------------------------------------------------------------------------------------------
ASCs..........................................            $192  $1,066,944 for 5,557 ASCs.
Hospices (freestanding/home-based)............             138  $557,520 for 4,040 hospices.
PACEs.........................................             173  $40,193 for 233 PACE organizations.
HHAs..........................................             314  $3,970,248 for 12,624 HHAs.
CORFs.........................................             294  $55,272 for 188 CORFs.
Organizations.................................             147  $305,172 for 2,076 Organizations.
CMHCs.........................................             138  $22,218 for 161 CMHCs.
OPOs..........................................             226  $13,137 for 58 OPOs.
RHCs/FQHCs....................................             256  $3,086,721 ($1,067,040 for 4,160 RHCs and
                                                                 $2,019,681 for 7,874 FQHCs).
----------------------------------------------------------------------------------------------------------------

    We will submit a revised information collection request to OMB to 
account for the burden hour and cost savings.

IV. Response to Comments

    Because of the large number of public comments we normally receive 
on Federal Register documents, we are not able to acknowledge or 
respond to them individually. We will consider all comments we receive 
by the date and time specified in the DATES section of this preamble, 
and, when we proceed with a subsequent document, we will respond to the 
comments in the preamble to that document.

V. Regulatory Impact Analysis

A. Statement of Need

    All major and many ostensibly minor government regulations should 
undergo periodic review to ensure that they do not unduly burden 
regulated entities or the American people, and reflect current 
knowledge as to regulatory effects. In recent years, we have revised 
the CoPs and CfCs to reduce the regulatory burden on providers and 
suppliers. In doing so, 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 of 
care, and we identified non-regulatory changes that would increase 
transparency and allow CMS to become a better business partner. 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).

These reforms, however, did not exhaust the potential for burden-
reducing reforms. We have continued to consult with regulated entities, 
have reviewed new research findings, have reviewed comments on previous 
rulemakings, and in these and other ways have identified additional 
reforms. These reforms are addressed in this proposed rule.
    This proposed rule is not just a continuation of our efforts to 
reduce regulatory burden but also directly responds to the January 30, 
2017 Executive Order ``Reducing Regulation and Controlling Regulatory 
Costs'' (Executive Order 13771). We propose changes to the current CoPs 
or 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, and reducing the associated burden on patients.

B. Overall Impact

    We have examined the impacts of this rule as required by Executive 
Order 12866 on Regulatory Planning and Review (September 30, 1993), 
Executive Order 13563 on Improving Regulation and Regulatory Review 
(January 18, 2011), the Regulatory Flexibility Act (RFA) (September 19, 
1980, Pub. L. 96-354), section 1102(b) of the Social Security Act, 
section 202 of the Unfunded Mandates Reform Act of 1995

[[Page 47730]]

(March 22, 1995; Pub. L. 104-4), Executive Order 13132 on Federalism 
(August 4, 1999), the Congressional Review Act (5 U.S.C. 804(2)) and 
Executive Order 13771 on Reducing Regulation and Controlling Regulatory 
Costs (January 30, 2017).
    Executive Orders 12866 and 13563 direct agencies to assess all 
costs and benefits of available regulatory alternatives and, if 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety effects, distributive impacts, and equity). Section 
3(f) of Executive Order 12866 defines a ``significant regulatory 
action'' as an action that is likely to result in a rule: (1) Having an 
annual effect on the economy of $100 million or more in any 1 year, or 
adversely and materially affecting a sector of the economy, 
productivity, competition, jobs, the environment, public health or 
safety, or state, local or tribal governments or communities (also 
referred to as ``economically significant''); (2) creating a serious 
inconsistency or otherwise interfering with an action taken or planned 
by another agency; (3) materially altering the budgetary impacts of 
entitlement grants, user fees, or loan programs or the rights and 
obligations of recipients thereof; or (4) raising novel legal or policy 
issues arising out of legal mandates, the President's priorities, or 
the principles set forth in the Executive Order.
    A regulatory impact analysis (RIA) must be prepared for major rules 
with economically significant effects ($100 million or more in any 1 
year). We estimate that this rulemaking is ``economically significant'' 
as measured by the $100 million threshold, and hence also a major rule 
under the Congressional Review Act. Accordingly, we have prepared a RIA 
that, to the best of our ability, presents the costs and benefits of 
the rulemaking.
    In accordance with the provisions of Executive Order 12866, this 
regulation was reviewed by the Office of Management and Budget. This 
proposed rule would create ongoing cost savings to providers and 
suppliers in many areas. Other changes we have proposed would clarify 
existing policy and relieve some administrative burdens. We have 
identified other kinds of savings that providers and patients will 
realize throughout this preamble, and substantial lifesaving benefits. 
These life-saving effects arise by removing the incentives created by 
the current transplant center regulations to decline to transplant 
patients with slightly lower probability of success, and to decline to 
use organs with a slightly lower probability of success.
    We welcome public comments on all of our burden assumptions and 
estimates as well as comments identifying additional reforms that 
should be considered for future rulemakings. As discussed later in this 
regulatory impact analysis, substantial uncertainty surrounds these 
estimates and we especially solicit comments on either our estimates of 
likely impacts or the specific regulatory changes that drive these 
estimates.
    As stated in the ICR section of this proposed rule, we obtained all 
salary information from the May 2016 National Occupational Employment 
and Wage Estimates, United States by the Bureau of Labor Statistics 
(BLS) at https://www.bls.gov/oes/2016/may/oes_nat.htm and calculated 
the added value of 100 percent for overhead and fringe benefits.

                             Table 12--Section-By-Section Economic Impact Estimates
----------------------------------------------------------------------------------------------------------------
                                                                                                     Estimated
                                                                                     Number of        annual
 Provider and supplier type and description                Frequency                 affected       savings or
           of proposed provisions                                                    entities      benefits  ($
                                                                                                     millions)
----------------------------------------------------------------------------------------------------------------
Religious Nonmedical Health Care
 Institutions:
     Discharge Planning.............  As patients are discharged                      18               *
                                               (Estimated 619 annual discharges).
Ambulatory Surgical Centers:
     Governing Body and Management..  Upon failed hospital transfer                5,557               *
                                               agreement attempts.
     Patient Admission, Assessment    Every patient registration at an      5,557 (ASCs)             454
     and Discharge (History and Physical).     ASC or at a hospital outpatient/            5,031
                                               ambulatory surgery department.        (Hospitals)
     Medical Records................  Recurring annually................           5,557               0
Hospices:
     Drugs and Biologicals, Medical   Recurring annually................           1,151              80
     Supplies, and Durable Medical Equipment.
     Hospices That Provide Hospice    Recurring annually................           4,602               *
     Care to residents of a SNF/NF or ICF/
     IID.
     Hospice Aide and Homemaker       Recurring annually................           3,498               2
     Services.
Hospitals:
     Quality Assessment and           Recurring annually................           5,031              28
     Performance Improvement Program.
     Medical staff: Autopsies.......  Recurring annually................           5,031               0
     Infection Control..............  Recurring annually................           5,031             105
     Special requirements for         Recurring annually................           1,724              30
     hospital providers of long-term care
     services (``swing-beds'').
     Special Requirements for         Recurring annually................             574              62
     Psychiatric Hospitals.
Transplant programs:
     Various provisions related to    Recurring annually................             750  Not Quantified
     performance * *.
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               *

[[Page 47731]]

 
     Special requirements for CAH     Recurring annually................           1,246              86
     providers of long-term care services
     (``swing-beds'').
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          Annual............................             500              31
     technicians * * *.
     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       Recurring annually................          72,844              94
     Preparedness Program.
     Emergency Plan.................  Recurring annually................          68,254               7
     Training and Testing-Training    Recurring annually................          69,196              33
     Program.
     Training and Testing-Testing...  Recurring annually................          36,971               9
                                             -------------------------------------------------------------------
        Total Annual Savings................  ..................................  ..............           1,123
        Life-extending benefits for           ..................................  ..............  Not Quantified
         transplant patients.
----------------------------------------------------------------------------------------------------------------
* Amount is less than one 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.

C. Anticipated Effects
1. Effects on Religious Nonmedical Health Care Institutions
    As detailed in the Collection of Information section of this rule, 
we propose to reduce the discharge planning requirements for RNHCIs 
because RNHCIs do not provide medical treatment or services. Most 
patients are discharged to home or to another facility that also does 
not provide medical treatment or services. Although all patients must 
have a discharge planning evaluation, not all patients require a 
discharge plan. The discharge planning cost would be reduced by an 
estimated $27,013.16.
2. Effects on Ambulatory Surgical Centers and Hospital Outpatient/
Ambulatory Surgery Departments
    As of May 2017 there were 5,557 Medicare-participating ASCs. We 
proposed to revise the ASC CfCs in order to reduce unnecessary 
duplications and streamline processes in order to reduce ASC compliance 
burden while maintaining minimum standards for patient safety and care. 
The specific savings for each proposed change are described later in 
this section of this proposed rule. At Sec.  416.41(b)(3), we propose 
to remove the requirements related to transfer agreements and admitting 
privileges. This change would eliminate the administrative burden 
associated with preparing an agreement for signature and going through 
the hospital credentialing process in order to obtain admitting 
privileges. Currently, all Medicare-certified ASCs are meeting the 
transfer agreement or admitting privileges requirement with the 
exception of approximately twenty ASCs that have tenuous relationships 
with their local hospital. We estimate the ASCs that do have difficulty 
with meeting this requirement would appreciate the annual burden 
savings of 2 to 4 administrator hours spent on paperwork and 
documentation. For those already with the transfer agreements in place, 
there would not be any more follow-up burden related to renewals or 
updates to the documents. We estimate the savings at less than $10,000 
overall and largely believe this change will not produce significant 
savings, however, it does affect twenty or more ASCs in the short term 
by removing the transfer agreement requirement. We welcome any feedback 
related to the time and effort for those ASCs that have secured an 
agreement, and if we have underestimated the savings of removing this 
transfer agreement in the future. As previously discussed, the 
enactment of EMTALA and its increasingly effective enforcement over 
time has rendered these transfer and admitting privileges obsolete and 
unnecessary. To put this point in perspective, emergencies or other 
unforeseen adverse events can arise in any ambulatory medical or dental 
setting, or in home settings. Over time, ``911'' emergency calls and 
direct ambulance responses have become standard operating procedures 
virtually nationwide, regardless of the place in which the problem 
arose. Under modern procedures, emergency responders (and patients 
themselves) take patients to hospital emergency rooms without regard to 
prior agreements between particular physicians and particular 
hospitals. Indeed, the most appropriate emergency treatment setting for 
a particular patient may not be one involving such an agreement even 
where the agreement exists. Of course, nothing prevents particular 
arrangements where a hospital and ASC agree that this is beneficial for 
a particular type of surgery or patient condition and where patient 
transport can be appropriately arranged to reflect this. Accordingly, 
we estimate that there will be no consequential adverse health effects 
of this proposed change, and therefore estimate no medical costs.
    There will be competitive benefits in those places where an ASC 
will now be allowed to operate and provide care at reduced cost 
compared to inpatient treatment. Nonetheless, we believe that the 
number of affected areas and facilities are few, and that annual 
benefits are unlikely to reach the

[[Page 47732]]

million dollar range. We welcome comments on these effects and on the 
preceding analysis of health effects.
    At Sec.  416.52 we propose to replace the requirement that every 
patient must have a comprehensive H&P within 30 days prior to surgery 
in an ASC with a requirement that allows the operating physician and 
ASC to determine which patients would require more extensive testing 
and assessment prior to surgery. We believe that this change would 
reduce patient and provider burden in a multitude of ways that includes 
the community-based physician, the ASC, and the patient. We believe 
that in almost all situations ASCs can reasonably rely on existing H&P 
results that are more than 30 days old and then are updated by patient 
responses on the day of surgery, but we cannot forecast with any 
precision what medical specialty societies, ASC governing bodies, 
hospital governing bodies, or accreditation bodies will decide to do in 
replacing the current requirement. Therefore, we do not forecast 
specific cost savings at this time, and solicit public comments to help 
us with our estimate in the final rule.
    For ASCs, we believe this change would reduce administrative burden 
by decreasing the amount of time that ASC personnel spend following up 
on patient visits to obtain the necessary H&P information and that it 
will provide for an increase in scheduling flexibility for the 
facility. We believe these changes may have the effect of improving 
patient satisfaction and increasing positive patient referrals for the 
ASC.
    For community-based healthcare providers, to include primary care 
providers, we believe this change would reduce unnecessary examinations 
that are required to be performed and reduce administrative paperwork 
burden associated with providing ASCs with the necessary H&P 
documentation and additional testing requirements. This change may 
potentially provide an opportunity for increased access to community-
based providers because of available appointments that are not being 
filled by unnecessary patient appointments for H&P requirements for 
surgery in an ASC. Those vacant appointments may also generate more 
revenue.
    For patients, we believe this change would reduce the time spent to 
prepare for surgery (time in community-based physician office, travel 
time and costs, time missed from the work place and lost productivity) 
and the cost associated with co-pays and other healthcare cost sharing 
requirements.
    Finally, we believe this change would reduce expenses for 
healthcare insurers to include Medicare, Medicaid, and private 
healthcare insurance companies. This change would reduce costs 
associated with reduced pre-operative exams, laboratory testing, chest 
radiographs, and echocardiograms.
    It is difficult to estimate the savings from this change, because 
they depend on a number of factors previously described, and additional 
factors for which we do not have precise measures, such as the number 
of patients (both Medicare and non-Medicare) who received two or more 
ASC services within the 30-day window allowed for one physical 
examination. This is a common occurrence because, for example, patients 
often receive cataract surgery on one eye and then, a week later, on 
the other eye. Furthermore, there are an immense number of different 
outpatient surgical services. At present, for example, there are about 
137 services that account for about 90 percent of ASC volume, and these 
services are highly diverse, as shown in Table 13.

           Table 13--Twenty Most Frequent ASC Services in 2015
------------------------------------------------------------------------
                                                            Percent of
            Surgical service                   Rank           volume
------------------------------------------------------------------------
Cataract surgery w/IOL insert...........               1           18.60
Upper GI endoscopy, biopsy..............               2             8.2
Colonoscopy and biopsy..................               3             6.8
Lesion removal colonoscopy (snare                      4             5.6
 technique).............................
Inject foramen epidural: Lumbar, sacral.               7             4.8
After cataract laser surgery............               6             4.4
Injection spine: Lumbar, sacral (caudal)               8             3.3
Inject paravertebral: Lumbar, sacral....               9             3.1
Diagnostic colonoscopy..................               5             2.3
Colorectal screen, high-risk individual.              10             2.0
Colorectal screen, not high-risk                      12             1.9
 individual.............................
Cataract surgery, complex...............              11             1.6
Injection procedure for sacroiliac                    19             1.3
 joint, anesthetic......................
Cystoscopy..............................              15             1.2
Upper GI endoscopy, diagnosis...........              13             1.0
Inject spine, cervical or thoracic......              17             1.0
Revision of upper eyelid................              16             0.9
Lesion removal colonoscopy (hot biopsy                14             0.8
 forceps)...............................
Upper GI endoscopy, insertion of guide                18             0.8
 wire...................................
Carpal tunnel surgery...................              20             0.7
                                         -------------------------------
    Total...............................  ..............            70.4
------------------------------------------------------------------------
Source: MEDPAC. Ambulatory surgical center services. 2017, p. 140.

    In total, ASCs provided about 6.4 million services in 2015 (MEDPAC. 
Ambulatory surgical centers services, 2017, p. 139). If we assume that 
25 percent of these had two or more services within the 30-day 
``window'' allowed in the current rule, then another H&P with its 
associated battery of tests were required for each of the remaining 4.8 
million individuals. Assuming that 5 percent of these would otherwise 
have already had an overall H&P and associated tests within 30 days of 
the surgery, 4.56 million persons would then require a new H&P and 
tests before surgery under the current requirements. In the great 
majority of cases involving eye or eyelid surgery of one kind or 
another, the ophthalmology examination preceding the ASC surgery would 
not have involved a

[[Page 47733]]

comprehensive H&P or battery of tests, and a similar situation would be 
involved for most other surgeries preceded by specialist rather than 
primary care visits.
    Although we are unable to estimate the likely number of cases, one 
way to estimate the costs of these examinations and tests would be as 
follows. First, the H&P itself would cost approximately $100 (the exact 
amount depending on diagnostic details, and not necessarily 
corresponding to any particular payment schedule). The battery of tests 
would cost approximately $100, assuming both urine and blood testing, 
and, in some cases, an electrocardiogram, but only half of physical 
examinations (for example, few or no ophthalmologist exams) would 
include such tests. The travel of the patient to and from the physician 
office to obtain the examination and tests would on average require 1 
hour, which when valued at the average wage rate in the economy of $24 
(increased by 50 percent to include fringe benefits but not overhead) 
would cost about $36. In addition, ASCs incur substantial costs for the 
time and trouble needed to contact physician offices and arrange for 
the results to be delivered. The physician offices themselves would be 
put through the trouble of transferring those medical records. Assuming 
average time spent (the median would be less but a small number of 
difficult cases would bring the average well above the median) would 
reach 10 minutes, and the use of a general office clerk at $32 an hour, 
the cost per patient would average $5 per patient. A further cost 
arises because in many cases the examination and test results simply 
cannot be obtained timely, and a scheduled surgery has to be postponed. 
Assuming that in such cases a half hour of surgeon time (at $243 an 
hour) and a half hour of registered nurse (RN) time (at $69 an hour) is 
wasted, and that clerical time ($32 an hour) to reschedule averages 10 
minutes, the average cost per postponement would be $161. (In some of 
these cases patient time would be wasted, as well as the time of family 
members accompanying the patient--we have not estimated these costs.)
    Aggregating these calculations, one estimate of the annual costs of 
the current regulatory requirement, as shown in Table 14, could be as 
much as $972 million for ASCs and a similar amount for hospital 
outpatient surgery. For many and perhaps most cases, however, either 
the surgeon or the facility would decide that H&P information is needed 
for particular patients or particular procedures whether or not this 
regulatory requirement existed. Of course, it is unlikely that in such 
cases a strict 30-day window would be insisted on. Assuming that such 
examination and testing information would continue to be needed for 10 
percent of all patients, and that in half of these cases the 
information would require a new examination and tests within a 30-day 
window, the net costs of the current regulatory requirement would be 5 
percent less than the preceding calculations. Supposing that such 
examination and testing information would still be required for 50 
percent of all patients, the costs of the current requirement and hence 
the potential savings from its reform would fall much further. Absent 
more specific information, the estimates of potential costs and savings 
in Table 14 are suggestive but not robust until or unless improved 
through public comment and additional information. In our summary 
estimates, we have assumed a range of savings from zero to 50 percent, 
with a midpoint of 25 percent.
    As support for the 50 percent upper bound, we note that Chen CL, 
Lin GA, Bardach NS, Clay TH, Boscardin WJ, Gelb AW, Maze M, Gropper MA 
and Dudley RA, Preoperative Medical Testing in Medicare Patients 
Undergoing Cataract Surgery, New England Journal of Medicine 372:1530-
1538, April 16, 2015, find that approximately 53 percent of Medicare 
cataract patients undergo pre-operative testing, none of which is 
mandated by CMS regulation. If these patients' physicians are cautious 
enough to currently pursue more preoperative activity (testing, H&P, 
etc.) than what is required, or state or hospital rules are driving 
physician behavior beyond what Medicare necessitates, then there is 
little reason to believe that that behavior will change with the 
finalization of this rule. Given that other procedures tend to be more 
invasive than cataract surgery, pre-operative caution on the part of 
physicians is likely to be even greater in the non-cataract context. 
Indeed, Benarroch-Gampel J, Sheffield KM, Duncan CB, Brown KM, Han Y, 
Townsend CM and Riall TS, Preoperative Laboratory Testing in Patients 
Undergoing Elective, Low-Risk Ambulatory Surgery, Annals of Surgery 
256(3):518-528, September 2012, and Fischer JP, Shang EK, Nelson JA, Wu 
LC, Serletti JM and Kovach SJ, Patterns of Preoperative Laboratory 
Testing in Patients Undergoing Plastic Surgery Procedures, Aesthetic 
Surgery Journal 1(1):133-141, January 2014, find that almost two-thirds 
of hernia procedures are preceded by testing, as are 62 percent of 
ambulatory plastic surgeries. This leaves an upper bound of 33 to 38 
percent of non-cataract outpatient surgery H&P costs that could 
reasonably be expected to be avoided as a result of this rulemaking. In 
order to more successfully tailor the upper bound of potential cost 
savings to H&P activity--rather than just extrapolating from testing 
behavior--we request comment on the possibility of building on Chen et 
al.'s data and methodology to estimate the increased frequency of 
within-30-day office visits (presumed to be H&P) when ophthalmologist 
visits are at least 31 days prior to surgery relative to when 
ophthalmologist visits are no more than 30 days prior.
    As noted in the medical literature previously discussed, Chung F, 
Yuan H, Yin L, Vairavanathan S, and Wong DT. Elimination of 
preoperative testing in ambulatory surgery. Anesth Analg. 2009 Feb, 
108(s):467-75, there are no known consequential medical benefits from 
the testing often performed in association with the current regulatory 
requirements. This study covered hernia patients but similar results 
have been found in studies of cataract surgery. Accordingly, 
eliminating the testing could in theory produce very substantial annual 
ASC cost savings with no offsetting medical cost increases or harm to 
patients. H&P itself, however, is distinct from testing, and literature 
indicating that testing is wasteful does not necessarily speak to the 
importance of H&P. Therefore, if H&P is avoided, rather than more 
thoroughly integrated into same-day presurgical assessments, there 
could be adverse consequences to patients; these impacts have not been 
quantified.
    As discussed in ``Provisions of the Proposed Regulations,'' section 
II.D. 2. of this proposed rule, there is a similar regulatory 
requirement for hospital outpatient surgery. Based on the substantial 
similarity between these two service settings, we also propose to 
eliminate these requirements for such surgery. Although we do not have 
detailed data for hospital outpatient surgery, it is widely agree to be 
roughly equal in size and composition to ASC surgery, though spending 
is higher because a higher payment schedule is used by some insurers, 
including Medicare, for most hospital outpatient surgery. Regardless, 
estimates should be based on economic costs, not any particular payment 
schedules. Accordingly, potential total annual savings, and hence 
benefits, for both settings taken together could be as much as $1.7 
billion. This would depend on whether hospital-based outpatient

[[Page 47734]]

surgery decisions parallel those of independent ASCs.
    If, after ASCs and hospitals make policy decisions on which types 
of outpatient/ambulatory surgery patients would require a comprehensive 
H&P, it is found that only 50 percent of current costs were continued, 
potential total annual savings, and hence benefits, for both settings 
taken together could be as much as $908 million, assuming that 
hospital-based outpatient surgery H&P policy decisions parallel those 
of independent ASCs. Alternatively, if 75 percent of current costs were 
continued, potential savings would be only about $454 million annually. 
While the literature shows that we can be reasonably certain that for 
some procedures, such as cataract surgery, few or possibly even no 
costs would be self-imposed, there may be other procedures where 
ensuing policy decisions would retain all current history and physical 
requirements, though likely removing the strict 30-day rule. Because of 
the proposed requirements, and other uncertainties, the potential 
savings from lifting the current requirements encompass at least this 
broad range and quite possibly more. Because there is great uncertainty 
in these estimates we have decided not to present a predetermined 
figure in this proposed rule. Instead, we are requesting public 
comments on all the parameters of our estimates to inform the estimates 
we will make in the final rule. We welcome information on likely 
decisions in both ASC and hospital outpatient settings, and if possible 
for the most common procedures shown in Table 13 and for the likelihood 
and cost saving effects for procedure and patient categories where the 
facility chooses to retain an external H&P requirement, but extends the 
time window to a year or some other period that is far longer than 30 
days.

                      Table 14--Current Costs and Potential Annual Savings From Creating and Obtaining Examination and Test Results
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                            Twenty-five                    Seventy-five
                      Type of cost                           Unit cost      Number (M)     Current total      percent      Fifty percent      percent
                                                                                             cost ($M)     retained ($M)   retained ($M)   retained ($M)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Physical Examinations...................................            $100            4.56            $456            $114            $228            $342
Test Batteries..........................................             100            2.28             228              57             114             171
Patient Travel Cost.....................................              36            4.56             164              41              82             123
Administrative Cost to ASC..............................               5            4.56              23               6              11              17
Surgery Cancellations *.................................             161           0.228              37               9              18              28
                                                         -----------------------------------------------------------------------------------------------
    Total Cost, ASCs....................................  ..............  ..............             908             227             454             681
    Total Cost, Hospital Outpatient **..................  ..............  ..............             908             227             454             681
                                                         -----------------------------------------------------------------------------------------------
    Total Cost..........................................  ..............  ..............           1,815             454             908           1,362
                                                         -----------------------------------------------------------------------------------------------
    Total Savings.......................................  ..............  ..............  ..............           1,362             908             454
--------------------------------------------------------------------------------------------------------------------------------------------------------
* Based on information from a major ambulatory surgery facility, this estimate assumes that 5 percent of scheduled cataract operations are cancelled at
  the last minute since the required H&P information has not arrived from the physician office where the examination was performed and the tests ordered
  or performed. Staff salaries must still be paid. Our estimates assume one half hour of surgeon time wasted (at $243 an hour), one half hour of RN time
  wasted (at $69 an hour), and ten minutes of clerical time (at $32 an hour) to reschedule.
** Hospital outpatient savings assumed to be equal to ASC savings.

    We assume that the one-time costs of developing such policies for 
hospital outpatient surgery in 5,031 Medicare-participating hospitals 
would be the same in the aggregate, though the mix of personnel used 
would be somewhat different and the cost at free-standing hospitals 
would likely be several times higher (for example, for involvement of 
the governing body and legal review). About 3,200 of these hospitals 
are in multi-hospital systems that would, however, reap economies of 
scale, and about 574 are psychiatric hospitals that we assume rarely 
perform surgery. In total, we estimate that, first year savings for 
both types of facilities would be $38 million less, regardless of the 
replacement rules that each facility imposed on itself.
    There are possible alternatives, including limiting the regulatory 
reform to the lowest risk procedures, which would probably mean almost 
all procedures, excluding certain procedures from the regulatory 
reform, exempting ASCs, but not hospital outpatient departments, 
changing the 30-day requirement to something much longer in duration 
such as 6 months or a year, and likely others. Absent contrary 
evidence, however, we believe that relying on physician and facility 
judgment maximizes benefits and presents no consequential costs.
    We welcome comments on these estimates and on both the proposal and 
any alternatives, and particularly welcome any evidence-based 
information that would inform both our ability to provide cost savings 
estimates and a policy choice between either the proposed reform or an 
alternative.
3. Effects on Hospices
    As of May 2017 there are 4,602 Medicare participating hospices. We 
proposed to revise the hospice CoPs in order to reduce unnecessary 
duplications and streamline processes in order to reduce hospice 
compliance burden while maintaining minimum standards for patient 
safety and care.
    At Sec.  418.76(a) we propose to defer to State training and 
competency requirements, where they exist, for hospice aides. Deferring 
to state requirements would streamline the hiring process because 
hospices would not have to verify that a job candidate's qualifications 
meet or exceed the Federal standard in addition to verifying that the 
candidate meets State requirements.
    According to the BLS, 408,920 aides are currently employed in 
``home care''. The term ``home care'' encompasses both home health 
agency and hospice employers. There are 12,624 HHAs and 4,602 hospices, 
meaning that hospices represent 27 percent of the ``home care'' 
employer market. Thus, we conclude that hospices employ 110,408 aides 
(27 percent of all aide positions in ``home care''). Based on an 
informal survey conducted by the largest hospice industry association, 
76 percent of

[[Page 47735]]

States have their own training and competency requirements, accounting 
for approximately 83,910 aide positions. Hospices in these states would 
benefit from the proposed change because they would be permitted to 
rely on the completion of state mandated training and competency 
programs to assure that a candidate is qualified for employment, and 
would no longer have to take the additional step of verifying that each 
potential job candidate also meet the Federal requirements. We assume a 
25 percent turnover rate based on discussions with industry experts, or 
20,978 aide job listings per year. Based on an assumed 20 candidates 
that would require the qualifications verification per job listing, we 
estimate that hospices must verify the training and competency program 
content and format for 419,560 candidates per year. We assume that it 
would take 10 minutes per candidate to verify compliance with the 
Federal requirements, for a total of 69,927 hours per year nationwide. 
At a cost of $32 per hour for a general office clerk to perform this 
check, we estimate that hospices will save $2,237,664 annually.
    At Sec.  418.106(a) we propose to delete the requirement that a 
hospice must 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. Not requiring the specific pharmacy 
advisement function would allow for more streamlined interdisciplinary 
group meetings. We assume that 25 percent of hospices currently use 
their own staff (employee or contract) for this function, and that this 
staff member is typically the nurse member of the interdisciplinary 
group. The nurse member of the interdisciplinary group is also required 
by Sec.  418.56(a); therefore we believe that removing this requirement 
will not result in removing the expertise from the group. Rather, we 
believe that removing this requirement will remove the formulaic 
approach to interdisciplinary discussions whereby the group allots time 
in each meeting specifically for this discussion in order to assure 
regulatory compliance. In the absence of regulation, the 
interdisciplinary group would have the authority to decide whether the 
discussion is pertinent for a given patient and the information can be 
woven into the discussion at large. This approach has the potential to 
reduce the overall group discussion time, particularly for the 3 
members of the interdisciplinary group that are not charged with being 
the pharmacology expert. Based on 1.6 million hospice patients and an 
assumed 3 interdisciplinary group meetings per patient, there are a 
total of 4,800,000 interdisciplinary group meetings per year. We assume 
that each interdisciplinary group meeting includes 2 minutes of time 
specifically related to discussing the results of the pharmacy 
advisement service for purposes of complying with the regulation, or 
160,000 hours per year nationwide. At a cost of $299 per hour ($198 
physician + $53 social worker + $48 pastoral counselor), we estimate 
that removing this requirement would save $47,840,000 annually.
    Additionally, we believe that this change would reduce the 
specialist nursing time spent specifically on advisement services. We 
believe that moving away from a regulatory compliance ``check box'' 
approach would allow the specialist nurse to incorporate medication 
management more seamlessly into regular clinical practice. The 2008 
Hospice CoP final rule (73 FR 32088) estimated a 1 hour burden per 
patient for expert pharmacy services (30 minute initial advisement per 
patient + 2 15 minute update advisements) for a total cost of $69 per 
patient for all advisement services (updated to 2017 dollars). We 
estimate that this proposed change would reduce that time by 50 
percent, to 30 minutes per patient, resulting in a $35 per patient 
savings. Based on the assumption that 25 percent of hospices use their 
own employee to perform this function, we estimate that this reduction 
would occur for 400,000 patients nationwide (25 percent of 1.6 million 
hospice patients), for a total annual savings of $14,000,000.
    Together with the previously stated estimate, total savings would 
be $47,840,000 + $14 million = $61,840,000 annually.
    We propose to revise the requirement at Sec.  418.106(d) to allow 
hospices to provide information regarding safe medication use, storage, 
and disposal in a more understandable manner. Under the current 
requirements, hospices are required to provide patients and families 
with a copy of the hospice's policies and procedures, which are not 
written in layperson terms. The proposed change would alleviate the 
burden associated with addressing the confusion created by the policies 
and procedures document. Following the initial cost of $483,210 
(described in section III.E. of this rule) for developing new, more 
easily understandable materials for patient education, we believe that 
hospices would realize a savings of 10 minutes per patient because it 
would require less hospice staff time to explain the more 
understandable material. Based on an assumed 10 minutes of saved 
nursing time per patient, and 1.6 million patients, hospices would save 
266,667 hours. At a cost of $69 per hour, the total savings would be 
$18,400,023.
    First year: $18,400,023 savings-$483,210 initial year cost = 
$17,916,813 net savings.
    Annually thereafter: $18,400,023 savings.
    At Sec.  418.112(f) we propose to allow hospices and long term care 
facilities the additional flexibility to negotiate the format and 
schedule for orienting long term care facility staff regarding certain 
hospice-specific information. We believe that this would allow for 
innovation and streamlining, and reduce hospice compliance costs 
related to this requirement by 20 percent. For purposes of our analysis 
only, we assume that a typical hospice conducts 6 orientation sessions 
per year, and that each orientation requires 2 hours of time from a 
hospice nurse. At a cost of $69 per hour, a typical hospice would spend 
$828 each year to orient long term care facility staff. Assuming a 20 
percent reduction in burden that can be achieved through innovation and 
streamlining, a typical hospice would save $166 a year, or $763,932 
savings annually for all 4,602 hospices.
    Taken together, these proposed reforms would generate annual 
savings of approximately $82.8 million ($47.8 million for reduced 
interdisciplinary group meeting time + $14 million for reduced 
specialty nursing time + $18 million for streamlined controlled drug 
education practices + $2.2 million for streamlined hospice aide 
qualification requirements + $0.8 million for streamlined facility 
staff orientation). We welcome public comment regarding these burden 
estimates, and additional regulatory reforms to reduce the burden of 
the hospice CoPs.
4. Effects on Hospitals
    As of May 2017, there were 5,031 Medicare participating hospitals. 
We propose to revise the hospital CoPs in order to simplify some 
requirements and streamline processes in order to reduce burden 
associated with hospital compliance with the Medicare CoPs while 
maintaining minimum health and safety standards. The specific savings 
for each proposed change are described below.

[[Page 47736]]

    At Sec.  482.21, we propose to allow for multi-hospital systems 
using a system governing body, as allowed under the CoPs, and that is 
legally responsible for two or more separately certified member 
hospitals, to have a unified QAPI program for the member hospitals 
subject to the system governing body. This will afford hospitals 
flexibility and the ability to gain efficiencies and achieve 
significant progress in quality by sharing best practices among all 
hospitals subject to the system governing body. This would be similar 
to current allowances for system governing bodies and unified medical 
staffs.
    While there are no current requirements that explicitly prohibit 
the sharing of best practices across a system, the current requirements 
for each hospital to have its own separate and distinct QAPI program 
and Infection Control program certainly have inhibited and stifled 
sharing of best practices and innovations among individual hospitals 
within a system as we point out in the preamble to this proposed rule, 
and which we support with our reference to the Health Research and 
Educational Trust, in partnership with the American Hospital 
Association March 2010 publication entitled, ``A Guide to Achieving 
High Performance in Multi-Hospital Health Systems.'' This publication, 
along with positive public comments regarding unified medical staffs 
that we discussed in the May 2014 final rule and to which we refer in 
this proposed rule, clearly point to multi-hospitals more efficiently 
and effectively collecting, disseminating, and sharing innovations, 
solutions, and best practices for patient care to each of its member 
hospitals through these unified patient care programs.
    Approximately 3,200 of the 5,031 Medicare-participating hospitals 
participate in a hospital system (American Hospital Association (AHA), 
Fast Facts 2017 (https://www.aha.org/system/files/2018-01/fast-facts-us-hospitals-2017_0.pdf)). According to the 2017 AHA Guide, there are 
424 multi-hospital systems. The current regulatory burden for 
compliance with the QAPI program requirement is approximately $10,000 
annually per hospital or $50.3 million annually for all 5,031 
hospitals. If we were to allow a unified QAPI program for multi-
hospital systems, this would remove 3,200 hospitals from the total 
5,031 (replaced by the 424 multi-hospital systems) for a total of 2,255 
hospitals/multi-hospital systems that would still need to comply. The 
new regulatory burden would be a total of approximately $22.6 million 
annually (2,255 x $10,000), for an annual total savings of 
approximately $28 million. We welcome comments on the quantitative and 
non-quantitative portions of the preceding discussion and seek any 
empirical evidence that would improve the accuracy and thoroughness of 
the relevant benefits estimation.
    We propose to remove the requirement for hospitals at Sec.  
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. Because this requirement is redundant and 
more detailed, specific requirements regarding medical-legal 
investigative autopsies are required by individual state law, we do not 
anticipate that hospitals would accrue additional savings from this 
change. The benefit to hospitals from eliminating this requirement is 
realized through a reduction in burden from no longer having to comply 
with two similar requirements of the Federal government and the State 
government. Hospitals would instead be required to follow the more 
detailed, specific regulations of the state in which they are located.
    At Sec.  482.42, we propose to allow for multi-hospital systems 
using a system governing body as currently allowed under the CoPs, and 
that is legally responsible for two or more separately certified member 
hospitals, to have a unified infection control program for those member 
hospitals subject to the system governing body. This would allow 
hospitals flexibility and the ability to gain efficiencies and achieve 
significant progress in infection prevention and control. This would 
also be similar to current allowances for system governing bodies and 
unified medical staffs.
    The current regulatory burden for compliance with the Infection 
Control program requirement is approximately $191 million annually for 
all hospitals or $38,000 per hospital. If we were to allow a unified 
Infection Control program for multi-hospital systems, this would remove 
3,200 hospitals from the total 5,031 (replaced by the 424 multi-
hospital systems) for a total of 2,255 hospitals/multi-hospital systems 
that would still need to comply. The new regulatory burden would be a 
total of approximately $86 million annually (2,255 x $38,000), for an 
annual total savings of approximately $105 million. We welcome comments 
on the quantitative and non-quantitative portions of the preceding 
discussion and seek any empirical evidence that would improve the 
accuracy and thoroughness of the relevant benefits estimation. At 
Sec. Sec.  482.58(b)(1) and 485.645(d)(1) (cross-referenced long-term 
care requirement at Sec.  483.10(f)(9)) we propose to remove the 
requirement for hospital and CAH swing-bed providers to provide the 
right for patients to choose to or refuse to perform services for the 
facility and if they so choose, (a) document in the resident's plan of 
care, (b) noting whether the services are voluntary or paid and (c) 
provide wages for the work being performed given the location quality, 
and quantity of work requiring comparable skills. We discuss the 
economic impact for this provision in the ICR section of this rule, 
which is estimated to be $32 million.
    At Sec.  482.58(b)(4) (and Sec.  485.645(d)(4)) (cross-referenced 
long-term care requirement at Sec.  483.24(c)), we propose to remove 
the requirement for hospital and CAH swing-bed providers to provide an 
ongoing activity program that is directed by a qualified therapeutic 
recreation specialist or an activities professional who meets certain 
requirements as listed at Sec.  483.24(c)(2). We discuss the economic 
impact for this provision in the ICR section of this rule, which is 
estimated to be $81 million.
    We propose to remove the requirement at Sec. Sec.  482.58(b)(5) and 
485.645(d)(5) (cross-referenced long-term care requirement at Sec.  
483.70(p)) for hospital and CAH swing-bed providers to employ a 
qualified social worker on a full-time basis if the facility has more 
than 120 beds. Given that this provision is not applicable to either 
provider type due to the regulatory requirements for each, it does not 
impose a burden upon hospitals and as such, its removal would not 
result in a savings of burden hours or dollars.
    At Sec. Sec.  482.58(b)(8) and 485.645(d)(8) (cross-referenced 
long-term care requirement at Sec.  483.55(a)(1)) we propose to remove 
the requirement for hospital and CAH swing-bed providers to assist in 
obtaining routine and 24-hour emergency dental care to its residents. 
We discuss the economic impact for this provision in the ICR section of 
this rule, which is estimated to be $2.9 million for all hospital and 
CAH swing-bed providers.
    At Sec.  482.61(d), we propose to allow non-physician practitioners 
to document progress notes in accordance with State laws and scope of 
practice requirements. We discuss the economic impact for this 
provision in the ICR section, which is estimated at $54.7 million in 
savings for psychiatric hospitals.

[[Page 47737]]

5. Effects on Transplant Programs and Patients
    There are approximately 750 Medicare approved transplant programs 
in the United States, of which 250 are kidney transplant programs. All 
Medicare approved transplant programs must be a part of a Medicare 
approved hospital, and many hospitals have several types of organ 
programs. Oversight of these programs occurs in two major ways: By the 
Organ Procurement and Transplantation Network (OPTN), which is a non-
profit membership-based organization operated under a Federal contract 
administered by the Health Resources and Services Administration 
(HRSA), and by CMS under the CoPs. The current and long-term OPTN 
contractor is the United Network for Organ Sharing (UNOS), which 
performs many transplantation functions, including matching donated 
organs to waiting lists of patients who have failing organs, and 
reviewing the performance of transplant centers on a variety of 
criteria, including patient and organ survival. There is a third 
mechanism encouraging better transplant program performance, the SRTR 
(accessed at https://www.srtr.org). The SRTR, also operated under a 
HRSA contract, provides detailed data on the performance of all 
transplant programs, and allows the OPTN, individual transplant 
programs, and patients themselves to compare results on such vital 
metrics as patient survival rates after transplant.
    For patients with most types of organ failure, a transplant is the 
only option for long-term survival. In the case of kidney failure, 
however, kidney dialysis is a viable medium-term and sometimes long-
term option for most patients. On average these patients can survive a 
dozen or more years on dialysis; however, without a transplant, they 
suffer increasingly high morbidity and mortality rates. We provide 
Medicare coverage for such patients through the ESRD program. Under the 
ESRD program, patients receive dialysis treatment, usually three times 
a week, through machines that cleanse their blood in much the same way 
as healthy kidneys would do. Since its inception in 1973, more than one 
million patients have received treatment under this program. Kidney 
failure patients are unique in another way: Unlike most other organs, 
with the partial exception of some liver donations, it is possible for 
living individuals to donate ``live'' kidneys, whether the living donor 
is a relative or an unrelated altruistic donor. In the case of ESRD 
patients, the Medicare ESRD program serves almost all kidney failure 
patients, regardless of age, and these patients receive costly dialysis 
for a prolonged period of time. As is the case for all CoPs, our 
regulations for Medicare-approved organ transplant programs have the 
potential to protect all patients, not just Medicare beneficiaries.
    As discussed earlier in this preamble, we have long regulated 
transplant programs, but put in place additional CoPs in the March 2007 
final rule (72 FR 15198) in an effort to increase the quality of care 
by specifying minimal health and safety standards. In addition, outcome 
metrics (1 year graft and patient survival) were included in the 
regulation and mirrored the OPTN outcomes metrics as calculated by the 
SRTR. Over time, increased emphasis on organ and patient survival 
rates, as key metrics of transplant performance, created incentives for 
transplant programs to select organs most likely to survive after 
transplant without rejection, and to select recipients most likely to 
survive after the transplant. In particular, due to the increasing 
patient and organ survival rates over time, the 2007 standards have 
become increasingly stringent over time as an artifact of the 
performance calculation method established in the 2007 rule, an outcome 
that was never intended by CMS. In addition, the 2007 rule created 
performance standards that focused only on organ and patient survival 
rates for those who received a transplant, not on survival rates of 
patients awaiting transplant. We refer readers to a discussion of this 
problem in the following CMS compliance Guidelines that could only 
partially lighten this unintended regulatory burden at https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-16-24.pdf.
    There is extensive literature on these incentives and other 
phenomena in transplant medicine that strongly suggests some unintended 
consequences on organ utilization (decreased use of ``marginal'' organs 
in their patients) and de-selection of some patients who are slightly 
less likely to survive for an extended period post-transplant. These 
unintended consequences have been anecdotal and measuring the extent to 
which they have occurred is difficult. In addition to the studies 
previously cited in the preamble (Adler et al., Schold et al., Dolgin 
et al., Stewart et al., Husain et al.), other studies on this issue 
include Kasiske B, Salkowski N, Wey A, Israni A, and Snyder J, 
``Potential Implications of Recent and Proposed Changes in the 
Regulatory Oversight of Solid Organ Transplantation in the United 
States,'' American Journal of Transplantation, Volume 16, Issue 12, 
December 2016, pages 3371-3377; Howard R, Cornell D, and Schold J, 
``CMS Oversight, OPOs and transplant centers and the law of unintended 
consequences, Clinical Transplantation, Volume 23, Issue 6, November/
December 2009, pages 778-783; and Abecassis M, Burke R, Klintmaim G, 
Matas A, Merion R, Millman D, Olhoff K, and Roberts J, ``American 
Society of Transplant Surgeons Transplant Center Outcome Requirements--
A Threat to Innovation,'' American Journal of Transplantation, Volume 
9, Issue 6, June 2009, pages 1279-1286; and Schold J, Miller C, 
Mitchell H, Buccine L, Flechner S, Goldfarb D, Poggio E, and Andreoni 
K, ``Evaluation of Flagging Criteria of United States Kidney Transplant 
Performance: How to Best Define Outliers,'' Transplantation, June 2017, 
Volume 101, Issue 6, pages 1373-1380. These studies regarding the 
reduced number of transplants that would otherwise have occurred, 
yielded several relevant facts. The number of deceased donor organs 
that are discarded has been increasing over time and for kidneys, is 
above 20 percent. For example, about 33 percent of kidneys recovered 
from donors age 50 to 64 are discarded, as are about 62 percent of 
kidneys recovered from donors age 65 or older (Hart A. et al., OPTN/
SRTR 2015 ``Annual Data Report: Kidney.'' Accessed at http://onlinelibrary.wiley.com/doi/10.1111/ajt.14124/full). Officials of the 
UNOS have stated at public meetings that in their judgment up to 1,000 
kidneys of the approximately 3,000 that are discarded each year are of 
good enough quality to be transplanted successfully. The number of 
organ transplantations reached record highs in 2016 (33,500), about 20 
percent more than 5 years earlier, due mainly to increased donation 
rates (OPTN, ``United States organ transplants and deceased donors set 
new records in 2016.'' Accessed at https://optn.transplant.hrsa.gov/news/us-organ-transplants-and-deceased-donors-set-new-records-in-2016/
).
    For purposes of this analysis, one approach to estimating effects 
is to isolate the number of kidneys (and other organs) that have been 
discarded as a result of the March 2007 rule; indeed, a reasonable 
assumption would be that this proposed rule's rescission of the 2007 
requirements would have an equal and opposite effect. A slide 
presentation by UNOS researcher Darren Stewart (2017; accessed at 
https://www.myast.org/sites/default/files/ceot2017/AST%20CEOT%2001%20

[[Page 47738]]

Stewart%20-%20No%20Organ%20Left%20Behind%20-%20S3.pdf), presents an 
estimate that about 1,110 of about 2,759 kidneys discarded in 2012 were 
of transplant quality and that between 500 and 1,000 of these could 
have been used in transplants (the most recent discard numbers, for 
2016, are about 20 percent higher than in 2012 and one-third higher 
than in 2007). This presentation cites the study previously discussed 
in this preamble (Stewart et al. (2017)), that shows kidney discard 
rates rising from between 5 and 7 percent in the late 1980s to 19.2 
percent in 2015. Notably, the discard rate had already reached 
approximately 18 percent by 2007, making the rate of increase much 
lower after the March 2007 rule was implemented than it had been in the 
previous two decades. Although this contrary evidence is far from 
definitive, it suggests that the effect of the March 2007 rule was too 
small to be observable in the kidney discard data.
    Unfortunately, these and other studies have had to deal with other 
trends during the last two decades that greatly complicate measuring 
the independent effect of the 2007 rule. These include the increasing 
age of the donor pool and the attendant decline in some dimensions of 
organ quality, and the opposite effects of improved techniques for 
maintaining organ quality between the time of donation and the time of 
transplantion. As a result, the published studies using data on organ 
discards have had to use complicated multivariate statistical 
procedures in attempting to estimate the effects of the 2007 rule, and 
invariably conclude that their findings are subject to considerable 
uncertainty.
    The preceding analysis focuses on discard rates as a tool that 
transplant programs can use to reduce risk of lower patient or organ 
survival rates, and hence risk of closure under the 2007 rule. A second 
tool that a transplant program can use to reduce its risk of lower 
overall patient survival rates is to remove patients who are slightly 
less likely to survive from its waiting list, most commonly by making a 
judgmental decision that the patient is ``too sick for 
transplantation.'' Programs that are on the margin of receiving 
regulatory sanctions, or that have received such sanctions already, are 
particularly likely to exercise such judgments to reduce regulatory 
risk. Several studies have estimated specific numbers of transplant 
reductions due to the 2007 rule by comparing the number of patients 
removed from the waiting list at programs that have received regulatory 
sanctions to those that have not. To provide a baseline, these studies 
make the conservative assumption that those programs with zero 
sanctions have not removed any patients from their transplant waiting 
list in order to avoid sanctions. For kidneys, one study estimated that 
in the seven year period from 2007 to 2014, the lower performing 
programs removed from waiting lists over 2500 patients more than would 
have been expected absent sanctions, an average of over 350 per year 
(J.D. Schold et al., ``Association of Candidate Removals From the 
Kidney Transplant Waiting List and Center Performance Oversight,'' 
American Journal of Transplantation 2016, 1276-1284). The implications, 
for the present time, of wait list changes initiated in 2007 is 
unclear. Increased mortality in 2007 among the very sick patients who 
were dropped from the wait list would have freed up organs for 2007's 
moderately sick patients; these patients otherwise would have declined 
in health so as to be the very sick population in 2008. Thus the 
absolute level of health in 2008 would have been relatively good, in 
which case the phenomenon of patients being dropped from the wait list 
might not have perpetuated into the future, leaving little or no scope 
for benefits to be achieved now as a result of the proposed CoP 
revision. (We note that one year, from 2007 to 2008, may be an 
exaggeration as to the short-term nature of this wait list-related 
effect, but a somewhat longer tapering period could still have reached 
completion now, more than a decade after the implementation of the 2007 
CoP, thus leaving little scope for benefits.) On the other hand, if the 
sickest patients in 2008 were dropped based on their relative health 
levels--in spite of their improved absolute health relative to the 
sickest patients in 2007--there would be potential wait list-related 
benefits from revising this CoP at the present time. The benefits of 
shifting transplants to the sickest patients from relatively less sick 
patients have not been quantified, but because the harm to the less 
sick patients would need to be netted off the benefit to the sickest 
patients, the per-transplant magnitude would be much lower than the 
per-transplant benefits of avoided organ discards.
    Another quantitative study of kidney transplant effects used a 
similar methodology and estimated that as a result of the 2007 rule, in 
2011 sanctioned programs performed 766 fewer kidney transplants than 
would otherwise have been the case (Sarah L. White et al., ``Patient 
Selection and Volume in the Era Surrounding Implementation of Medicare 
Conditions of Participation for Transplant Programs,'' Health Services 
Research, April 2015, 330-350). White et al.'s finding of reduced 
transplant volumes at particular kidney transplant centers does not 
necessarily indicate decreased transplant volumes overall, with the 
authors stating that their aggregate results ``do not indicate that the 
introduction of the [2007] CoPs has systematically reduced 
opportunities for marginal candidates or that there has been a 
systematic shift away from utilization of higher risk deceased donor 
kidneys.'' In other words, regulatory sanctions could have triggered 
behavioral responses by some patients, some transplant surgeons, or 
some health insurance plans to shift patients away from these centers 
(many insurers restrict coverage through ``centers of excellence'' 
programs). Schold et al. (2013) find additional support for this 
phenomenon, describing their empirical result as follows: ``Among 203 
[adult kidney transplant] centers, 46 (23%) were low performing (LP) . 
. . Among LP centers, there was a mean decline in transplant volume of 
22.4 cases compared to a mean increase of 7.8 transplants among other 
centers.'' The estimated decrease per low-performing transplant center 
is roughly three times the increase per other center, but there are 
also roughly three times as many other centers as low-performing 
centers; as such, the most straightforward interpretation of this paper 
is that the same number of transplants is being concentrated in a 
smaller number of transplant centers. This outcome could still have 
real impacts, such as changes in travel time for patients, but although 
these impacts are valid for inclusion in a regulatory impact 
assessment, they would be much smaller in magnitude than the longevity 
benefits emphasized elsewhere in this analysis.
    A feature common to most of these studies that is that they use 
data that are already several years old when the study is published, 
both because of the usual publishing lag and because performance data 
such as one-year survival rates necessarily make transplant program 
results less timely. None of these studies covers the last two or three 
years of transplant program performance. As a result, none of these 
studies has been able to use actual data to assess the effects of the 
May 13, 2016 CMS changes that slightly reduced the performance level 
for finding a ``condition-level'' violation that threaten's program 
closure. For recent reviews of potential effects of those changes see 
B.L. Kasiske et al., ``Potential Implications of Recent and

[[Page 47739]]

Proposed Changes in the Regulatory Oversight of Solid Organ 
Transplantation in the United States,'' Am J Transplant, December 2016, 
16(12), 3371-3377, and Colleen Jay and Jesse Schold, ``Measuring 
transplant center performance: The goals are not controversial but the 
methods and consequences can be,'' Curr Transplant Rep, March 2017, 
4(1), 52-58. Using past data to measure potential effects, these 
studies predict little or no positive effect from the revised standards 
(which both studies conclude will still mis-identify lower performing 
programs), but cannot evaluate actual effects because post-issuance 
evidence is not yet available. This may not be relevant policy-wise, 
since we propose to eliminate those standards, but it is a key question 
for estimating the remaining scope (if any) of CoP-associated 
unnecessary organ discards, and it does flag the pervasive problem of 
timeliness of data and timeliness of study findings.
    There are several studies that make similar estimates for liver 
transplant programs (for example, L.D. Buccini, et al., ``Association 
Between Liver Transplant Center Performance Evaluations and Transplant 
Volume,'' American Journal of Transplantation 2014, 2097-2105). This 
study found a large difference in transplant volume between programs 
rated as lower performing by the SRTR (average decrease of 39.9 
transplants from 2007 to 2012) and those not receiving adverse SRTR 
ratings (average increase of 9.3 transplants over the same period). The 
27 lower performing centers thus reduced their total number of liver 
transplants by over 1,000, and compared to the higher performing 
centers the decrease was even larger. This study did not, however, tie 
its estimates to the performance standards in the 2007 rule (which are 
similar but not identical to SRTR standards), to sanctions under that 
rule, or to specific center decisions, such as removing candidates from 
the wait list. Hence, while it certainly contributes to the body of 
scholarship indicating that since 2007 transplants have been performed 
in a more concentrated set of programs, it does not appear to provide 
direct estimates of the quantitative effects of the 2007 rule on 
overall numbers of liver transplants.
    Taking into account all the various uncertainties involved in these 
studies, we do not believe that we can estimate the effects of the 2007 
rule on numbers of transplantations for any organ other than kidneys, 
and that even for kidneys there is no clear central estimate of likely 
quantitative effects. The wide variation in published results, and the 
disclaimers as to the various uncertainties involved, make a precise as 
well as reliable estimate all but impossible and would render arbitrary 
any non-zero lower bound estimate of health and longevity impacts. (As 
noted above, however, even in the absence of health and longevity 
effects, there may be other benefits, such as reduced travel costs, if 
the proposed rule reduces concentration of transplants in a smaller 
number of facilities.) Therefore, we have shown the effects of the 
proposed change as ``not quantified.'' This is not unusual in 
Regulatory Impact Analyses that address complex phenomena that cannot 
be measured directly, or whose effects are intertwined with other 
changing circumstances. That said, we welcome any additional 
information that might allow a quantitative estimate in the final rule.
    Every transplant quality organ that is used for transplantation 
rather than discarded has a very high probability of substantially 
extending the life of the recipient. There is a particularly extensive 
literature on life expectancy before and after transplant, quality of 
life, and cost savings for kidney patients. A literature synthesis on 
``The Cost-Effectiveness of Renal Transplantation,'' by Elbert S. 
Huang, Nidhi Thakur, and David O. Meltzer, in Sally Satel, When 
Altruism Isn't Enough (AEI Press, 2008) found essentially universal 
agreement that kidney transplants were not only substantially life 
extending, but also cost reducing. The authors performed an extensive 
literature search and found that from 1968 to 2007 seventeen studies 
assessed the cost-effectiveness of renal transplantation. The authors 
concluded that ``Renal transplantation . . . is the most beneficial 
treatment option for patients with end-stage renal disease and is 
highly cost-effective compared to no therapy. In comparison to 
dialysis, renal transplantation has been found to reduce costs by 
nontrivial amounts while improving health both in terms of the number 
of years of life and the quality of those years of life'' (page 31). 
More recent studies have reached similar conclusions, as have other 
syntheses. For example, the ``Systematic Review: Kidney Transplantation 
Compared with Dialysis in Clinically Relevant Outcome'' (M. Tonelli, N. 
Wiebe, G. Knoll, A. Bello, S. Browne, D. Jadhov, S. Klarenbach, and J. 
Gill, American Journal of Transplantation 2011: 2093-2109) focused on 
life expectancy and quality of life. This article reviewed 110 studies, 
and concluded that the vast majority showed major improvement in life 
quality and reductions in mortality among transplant recipients 
compared to those remaining on dialysis. The Annual Data Report of the 
United States Renal Data System utilizes national data on ESRD, and 
reports that deaths per 1,000 patient years are about 180 for dialysis 
patients and about 32 for transplant recipients (see 2016 report, 
volume 2, Figure i.13 and Tables H.4 and H.10; accessed at https://www.usrds.org/adr.aspx). There are similar data on other organs. For 
example, in 1998, HHS published a final rule with comment period that 
established governance procedures for the OPTN (63 FR 16296). In the 
RIA for that rule, the Department estimated that ``the annual benefits 
of organ transplantation include about eleven thousand lives vastly 
improved by kidney transplantation, and another eight thousand lives 
both vastly improved and prolonged by transplantation of other major 
organs'' (63 FR 16323).
    Even without a robust aggregate estimate of likely increases in 
organ utilization as a result of this proposed regulatory change, the 
potential benefits are very substantial. For each new kidney 
transplantation, there would be an average of 10 additional life years 
per transplant patient compared to those on dialysis (see Wolfe A. et 
al., ``Comparisons of Mortality in All Patients on Dialysis, Patients 
on Dialysis Awaiting Transplantation, and Recipients of a First 
Cadaveric Transplant,'' NEJM, 1999, 341:1725-30; accessed at http://www.nejm.org/doi/full/10.1056/NEJM199912023412303#t=article). Valuing 
each year of life gained using a ``value of a statistical life year'' 
(VSLY) of $490,000 in 2014 dollars, the total benefits from each 
additional transplantation in 2018 would be $4.9 million before 
discounting and $4.4 million after inflating to 2016 dollars and 
discounting at either 3 percent over the 10-year period (life-year 
figure for 2014 from Office of the Assistant Secretary for Planning and 
Evaluation, HHS, Guidelines for Regulatory Impact Analysis, 2016, page 
21, accessed at https://aspe.hhs.gov/pdf-report/guidelines-regulatory-impact-analysis). The HHS methodology produces the same result at 
either discount rate in order to reach the same predetermined ``real'' 
value. For an explanation and justification of this VSLY approach, see 
Cass R. Sunstein, ``Lives, Life-Years, and Willingness to Pay,'' 104 
Columbia Law Review [i] (2004).
    Those HHS guidelines also explain in some detail the concept of 
quality adjusted life years. The key point to understand is that these 
are research-based estimates of the value that people

[[Page 47740]]

are willing to pay for life-prolonging and life-improving health care 
interventions of any kind (see sections 3.2 and 3.3 of the HHS 
Guidelines for a detailed explanation). The QALY amount used in any 
estimate of overall benefits is not meant to be a precise estimate, but 
instead is a rough statistical measure that allows an overall estimate 
of benefits expressed in dollars.
    An alternative and more sophisticated analysis would take into 
account that the life-extending effect of a kidney transplant is not 
its first effect, but typically follows a number of years off dialysis, 
until the organ fails and the patient returns to dialysis or is 
retransplanted. Such an analysis can be found in a recent study by P.J. 
Held et al., ``A Cost-Benefit Analysis of Government Compensation of 
Kidney Donors,'' American Journal of Transplantation, 2016, pages 877-
885 (plus 65 pages of supplementary details explaining all assumptions, 
data sources, and calculations). The largest differences between the 
base case estimated in that study and the preceding estimates is that 
this RIA uses the considerably higher value of a statistical year of 
life under HHS guidelines, and this RIA uses the full value of a 
statistical life year without a ``quality'' adjustment for the added 
years of life (we use QALYs only for the improved quality of life 
during years that would otherwise be on kidney dialysis). Under such an 
estimation approach, potential life-extending benefits could be 
somewhat larger. For example, if the proposed reform increased the 
number of life-extending kidney transplants by only 100 a year, and the 
benefits of both additional life years and QALY gains were estimated at 
$5.1 million per patient, its total annual benefits for kidney patients 
would be approximately $510 million a year (100 x $5.1 million).
    There are additional benefits from kidney transplantation. As 
previously discussed, kidney transplants do reduce medical costs, with 
``breakeven'' after about 5 years and net savings of several hundred 
thousand dollars per patient. Other organ transplants create lesser or 
no medical savings because the alternative is not dialysis. Clearly, 
however, these kidney transplant savings are small in relation to the 
life-extending benefits. We have not estimated medical savings or costs 
for kidneys or other organs in this RIA because any such estimates 
would depend on the number of additional transplants that we have not 
estimated.
    We welcome comments on the quantitative and non-quantitative 
portions of the preceding discussion and seek any empirical evidence 
that would allow robust estimates of benefits, and in particular robust 
quantitative estimates of the number of patients deprived of 
transplantation as a result of the 2007 rule, as currently implemented 
to reflect the 2016 guidance, for each organ type. We also welcome 
comments on whether we have accurately and reasonably summarized the 
research evidence on the effects of the 2007 rules, particularly in the 
light of the many other factors influencing transplantation trends and 
performance.
    We note that life-extending estimates are averages across patients 
who vary widely in age, medical condition, and life expectancy, as well 
as type of organ failure. For example, the sickest patients typically 
have very low life expectancies without transplant, and hence stand to 
gain the most years of life from a transplant. Partly offsetting this, 
these same patients, on average, have slightly lower survival rates 
post-transplant. Organ and patient survival issues are complex and 
dealt with by detailed policies and procedures developed and used by 
the transplant community under the auspices of the OPTN. These policies 
are reviewed and revised frequently based on actual experience and 
changing technology--over time the success rate from previously 
marginal organs, and in older patients, have both increased 
substantially. For purposes of this analysis, the proper measure is the 
average gain across all patients who would receive transplants as a 
result of eliminating the 2007 rule, net of these other factors.
    There could be potential offsets to these calculated and 
uncalculated benefits and cost reductions. However, the particular 
regulatory requirements we propose to remove are unlikely to drive any 
further significant increases in graft and patient survival. For renal 
transplants, the expected 1-year graft and patient survival rates are 
already at 95 percent or better. Transplant program outcomes will 
continue to be monitored by the OPTN and programs that are not in 
compliance with the OPTN outcomes are referred to their Membership and 
Professional Standards Committee for quality improvement activities. 
The SRTR also publishes detailed data on transplant program performance 
that allows patients and their physicians to compare transplant 
programs and this transparency creates pressures to maintain and 
improve survival rates in order to attract these patients.
    The current regulatory requirements for transplant centers, as 
discussed in section II.E ``Transplant Centers'' of this proposed rule, 
have created both positive and adverse incentives for transplant 
programs, with unanticipated side effects on both utilization of 
donated organs and the ability of the highest risk patients to obtain 
transplants. We expect the proposed change to provide substantial net 
benefits, particularly since other regulatory and informational 
incentives remain in place.
    We welcome comments on this analysis as well as information that 
would enable a more robust quantitative analysis of the impacts of this 
change and on any alternative reforms that might provide even higher 
benefits.
6. Effects on HHAs
    As of May 2017 there are 12,624 HHAs that participate in Medicare 
and Medicaid. In the January 2017 HHA CoP final rule (82 FR 4149) we 
estimated that compliance with the requirements at Sec.  484.50(a)(3) 
related to providing oral notice of all rights to each patient would 
impose a burden of 5 minutes per patient, or 330,246 hours of burden 
nationwide at a cost of $80,030,370, annually. The cost estimate was 
based on a $63 per hour estimate for the services of a RN as derived 
from the BLS Occupational Handbook, 2014-2015 edition, including a 100 
percent benefit and overhead package. Adjusted to reflect more updated 
salary information, as described previously, we estimate that 
compliance with this provision would impose a $91,786,974 burden, based 
on a RN earning $69 per hour.
    We propose to revise the verbal notification requirements to limit 
them to those that are required by section 1891 of the Act. Limiting 
the amount of information that is required to be provided orally will 
reduce the time per patient that is required to comply with the revised 
requirement. For purposes of this analysis only, we assume that 
providing oral notice regarding financial liability only will require 2 
minutes per patient, reducing burden by 60 percent. Based on this 
assumption, this proposed change would reduce the burden of the patient 
rights notification requirement by 198,148 hours (330,246 hours 
originally estimated x 0.6) and $55,072,184 ($91,786,974 burden as 
updated to reflect more recent salary estimates x 0.6).
    We also propose two changes that do not have a savings estimate. 
First, we propose to eliminate the requirement at Sec.  484.80(h)(3) 
that the HHA conduct a full competency evaluation of deficient home 
health aides, and replace it with a requirement to retrain the aide 
regarding the identified deficient skill(s) and require the aide to 
complete a competency evaluation related to those

[[Page 47741]]

skills. As we stated in the January 2017 HHA CoP final rule (82 FR 
4575), it is standard practice within the HHA industry to supervise 
home health aides, and the regulatory requirements for such supervision 
do not impose any additional burden.
    Second, we propose to remove the requirement at Sec.  484.110(e) 
related to providing a requested copy of the clinical record at the 
next home visit, while retaining the requirement to provide the record 
within 4 business days. As stated in the January 2017 HHA CoP final 
rule (82 FR 4568 and 4575), we believe that providing such information 
to patients is a usual and customary practice that does not impose a 
burden upon HHAs. As such, removing the ``next home visit'' timeframe 
requirement would not result in a savings of burden hours or dollars.
    We welcome public comment regarding these burden estimates, and 
additional regulatory reforms to reduce the burden of the HHA CoPs.
7. Effects on CAHs
    We propose to remove the requirement at Sec.  485.627(b)(1) for 
CAHs to disclose to CMS its owners or those with a controlling interest 
in the CAH or any subcontractor in which the CAH directly or indirectly 
ha a 5 percent or more ownership interest in accordance with 42 CFR 
part 420, subpart C. We discuss the economic impact of this provision 
in the ICR section, which is estimated at $141,000 total for all CAHs. 
We discussed the burden reduction for our proposed revision of the 
``patient care policies'' requirements imposed on CAHs in the ICR 
section of this rule, which is estimated at $2.5 million.
8. Effects on CORFs
    We discussed the burden reduction for our proposed revision of the 
``utilization review plan'' requirements imposed on CORFs in the ICR 
section of this rule, which is estimated at $309,072.
9. Effects on CMHCs
    We discussed the burden reduction for our proposed revision of 
Sec.  485.914(d)(1) ``update of the comprehensive assessment'' 
requirements imposed on CMHCs in the ICR section, which is an estimated 
savings of $152,464.
10. Effects on Portable X-Ray Services
    At Sec.  486.104 we propose to revise the portable x-ray CfCs to 
focus on the qualifications of the technologist performing the 
diagnostic test. As of May 2017 there were approximately 500 Medicare-
participating portable x-ray suppliers employing an estimated 5,000 
portable x-ray technologists. Hiring limited x-ray technologists or 
those with State licensure would allow portable x-ray suppliers to fill 
vacant positions at a lower hourly cost. Assuming a 10 percent annual 
turnover rate, all technologists could be hired at the lower salary 
over a period of 10 years. Limited x-ray technologists can be hired for 
approximately $30 an hour ($62,400 per year), whereas, according to the 
BLS, x-ray technologists with advanced certification (ARRT) are hired 
at a rate of approximately $60 dollars per hour ($124,800 per year). 
This creates a savings opportunity of $30 per hour, or $62,400 per 
year, per technologist position. Based on an assumed 10 percent 
turnover rate, or 500 positions filled in any given year, this change 
would create a savings of $31,200,000 savings in the first year. We 
believe that these savings would be increased every year as more 
positions are filled at the lower salary rate.
    We welcome public comment regarding these burden estimates, and 
additional regulatory reforms to reduce the burden of the portable x-
ray CfCs.
11. Effects on RHCs and FQHCs
    We discussed the burden reduction for our proposed revision of 
Sec.  491.9(b)(4) ``review of patient care policies'' requirements 
imposed on RHCs and FQHCs in the ICR section, which is an estimated 
savings of $6.8 million. In addition, the burden reduction for our 
proposed revision of Sec.  491.11(a) ``program evaluation'' 
requirements imposed on RHCs and FQHCs in the ICR section of this rule, 
which is an estimated savings of $9.4 million.
12. Effects of Emergency Preparedness Requirements on Providers and 
Suppliers
    This proposed rule revises the emergency preparedness requirements 
for Medicare and Medicaid participating providers and suppliers, as 
discussed in detail in section II.M of this proposed rule. The proposed 
modifications to the emergency preparedness requirements either 
simplify the requirements, eliminate duplicative requirements, or 
reduce the frequency in which providers would need to comply with the 
emergency preparedness requirements. We estimate that the proposed 
changes to the emergency preparedness requirements would accrue an 
annual cost savings of $155 million in total. The potential, estimated 
cost savings for each revised emergency preparedness requirement is 
outlined in detail below. The methodology used to calculate the 
economic impact and the costs associated with the proposed changes to 
the emergency preparedness requirements is the same methodology used to 
calculate the economic impact in the Emergency Preparedness final rule 
(81 FR 63860).
    At Sec.  482.15(a), (b), (c), and (d) for hospitals and parallel 
regulatory citations for other facilities, we propose to allow 
providers to review their program at least every 2 years. We discuss 
the economic impact for this requirement in the ICR section of this 
rule, which represents $94,312,719 in savings.
    At Sec.  482.15(a)(4) for hospitals, and other parallel citations 
for the facilities mentioned in section II.J.2 of this proposed rule, 
we propose to eliminate the requirement that facilities document 
efforts to contact local, tribal, regional, State, and Federal 
emergency preparedness officials and that facilities document 
participation in collaborative and cooperative planning efforts. We 
discuss the economic impact for this requirement in the ICR section of 
this rule, which represents $7,179,117 in savings.
    At Sec.  482.15(d)(1)(ii) for hospitals, and other parallel 
citations for other facilities mentioned in section II.J.2 of this 
proposed rule, we propose to require that facilities provide training 
biennially, or every 2 years, after facilities conduct initial training 
on their emergency program. In addition, we propose to require 
additional training when the emergency plan is significantly updated. 
We discuss the economic impact for this requirement in the ICR section 
of this rule, which represents $33,267,864 in savings. Finally, at 
Sec.  482.15(d)(2), we propose to require that providers of inpatient 
services mentioned in section II.J.2 of this proposed rule conduct two 
testing exercises annually, one of which may be an exercise of their 
choice that must be either a community-based full-scale exercise (if 
available), an individual facility-based functional exercise, a drill, 
a tabletop exercise or workshop that includes a group discussion led by 
a facilitator. We propose to require that providers of outpatient 
services mentioned in section II.J.2 of this proposed rule conduct one 
testing exercise annually which must be either a community-based full-
scale exercise (if available) or an individual facility-based 
functional exercise every other year, and in the opposite years, may be 
either 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. We

[[Page 47742]]

discuss the majority of this economic impact for this requirement in 
the ICR section, which represents $9,117,425 in savings. We do not 
estimate any economic impact for the providers of inpatient services as 
we are not proposing any changes to the number of testing exercises 
that must be conducted by these providers; however, we estimate an 
additional economic impact for this provision for each outpatient 
provider due to a reduction in the testing requirement from two 
exercises per year to one exercise per year. We would like to note that 
for CORFs and Organizations, consistent with the Emergency Preparedness 
Final Rule (Medicare and Medicaid Programs; Emergency Preparedness 
Requirements for Medicare and Medicaid Participating Providers and 
Suppliers; Final Rule, 81 FR 63860), the CoPs for these providers 
previously required them to have ongoing drills and exercises to test 
their disaster plans. Therefore, we continue to expect, as we did in 
the Emergency Preparedness final rule, that the economic impact to 
comply with this requirement will be minimal, if any. Therefore, the 
total economic impact of this provision for CORFs and Organizations 
will be limited to the estimated ICR burden of $55,272 and $305,172, 
respectively.
    We estimate a total impact savings of $10,997,373 for this proposed 
change. With an estimated ICR savings of $9,117,425, we estimate that 
the total economic impact of this rule for the affected providers will 
be $20,114,798. We list a summary of the calculation for the impact 
savings accrued by removing this requirement for each facility in Table 
15, based on facility numbers available as of May 2017.
     ASCs: Combined total savings of $1,967,178 for 5,557 ASCs 
((4 hours for an administrator at $108 per hour plus 4 hours for a 
registered nurse at $69 per hour) x 5,557 ASCs x 50 percent).
     Outpatient Hospice: Combined total savings of $1,405,920 
((4 hours for an administrator at $105 per hour plus 4 hours for a 
registered nurse at $69 per hour) x 4,040 outpatient hospices x 50 
percent).
     PACE: Combined total savings of $16,077 ((1 hour home for 
a care coordinator at $69 per hour plus 1 hour for a quality 
improvement nurse at $69) x 233 PACEs x 50 percent).
     HHAs: Combined total savings of $2,632,104 ((2 hours for 
an administrator at $105 per hour plus 3 hours for a director of 
training at $69 per hour) x 12,624 HHAs x 50 percent).
     CMHCs: Combined total savings of $58,926 ((5 hours for an 
administrator at $105 per hour plus 3 hours for a nurse at $69 per 
hour) x 161 CMHCs x 50 percent).
     OPOs: Combined total savings of $5,046 ((1 hour for a QAPI 
Director at $105 per hour plus 1 hour for an education coordinator at 
$69 per hour) x 58 OPOs x 50 percent).
     RHCs/FQHCs: Combined total savings of $ 4,187,832 (((4 
hours for an administrator at $105 per hour plus 4 hours for a 
registered nurse at $69 per hour) x 4,160 RHCs x 50 percent) plus (4 
hours for an administrator at $105 per hour plus 4 hours for a 
registered nurse at $69 per hour) x 7,874 FQHCs x 50 percent).
     ESRDs: Combined total savings of $724,290 ((1 hour for an 
administrator at $105 per hour plus 1 hour for a nurse manager at $105 
per hour) x 6,898 dialysis facilities x 50 percent).

        Table 15--Cost Savings for Emergency Preparedness Testing
------------------------------------------------------------------------
                                     Cost savings
         Provider/supplier           per provider/     Combined total
                                       supplier            savings
------------------------------------------------------------------------
ASCs..............................            $354  $1,967,178 for 5,557
                                                     ASCs.
Hospices (outpatient).............             348  $1,405,920 for 4,040
                                                     outpatient hospice
                                                     facilities.
PACEs.............................              69  $16,077 for 233
                                                     PACEs.
HHAs..............................             209  $2,632,104 for
                                                     12,624 HHAs.
CMHCs.............................             366  $58,926 for 161
                                                     CMHCs.
OPOs..............................              87  $5,046 for 58 OPOs.
RHCs/FQHCs........................             348  $4,187,832 for RHCs
                                                     and FQHCs
                                                     ($1,447,680 for
                                                     4,160 RHCs and
                                                     $2,740,152 for
                                                     7,874 FQHCs).
ESRD Facilities...................             105  $724,290 for 6,898
                                                     dialysis
                                                     facilities.
------------------------------------------------------------------------

13. One-Time Implementation Costs
    All of the changes presented above will necessarily have to be 
read, and understood, and implemented by affected providers. This will 
create one-time costs even though the underlying change reduces burden. 
In most cases these costs will be very low, and may be as simple as 
observing that a particular procedure will need only to be performed 
once rather than twice a year, and changing the schedule accordingly. 
In some cases, the facility will need to adjust in response to multiple 
burden reduction changes. In still other cases, time will have to be 
spent deciding how to change existing policy. For example, as discussed 
previously, ASCs and hospital outpatient facilities will need to decide 
whether and in what circumstances medical histories and physical 
examinations will be required or encouraged as a matter of policy. 
Rather than attempt to estimate these situational variables in detail 
for each facility type, we believe it possible to make reasonable 
overall estimates of these one-time costs, recognizing that there will 
be considerable variations among provider types and among individual 
providers.
    In total, there are about 122 thousand affected entities, as shown 
in the Table 17 that follows. We assume that on average there will be 1 
hour of time spent by a lawyer, 2 hours of time by an administrator or 
health services manager, and 2 hours of time by other staff (we assume 
registered nurses or equivalent in wage costs) of each affected 
provider to understand the regulatory change(s) and make the 
appropriate changes in procedures. We further estimate that for one 
tenth of these providers, 2 hours of physician time will be needed to 
consider changes in facility policy. Average hourly costs for these 
professions, with wage rates doubled to account for fringe benefits and 
overhead costs, are $134 for lawyers, $105 for managers, $70 for 
registered nurses, and $198 for physicians. These numbers are from BLS 
statistics for 2016, at https://www.bls.gov/oes/2016/may/oes_nat.htm.
    The estimated costs for an average provider would therefore be 1 
hour at $134 and in total for the lawyers, 2 hours at $105 or $210 in 
total for the managers, 2 hours at $69 or $138 in total for the other 
staff, and two-tenths of 1

[[Page 47743]]

hour at $198 or $40 in total for the physicians. These one-time costs 
add up to $522 per provider on average, and in total to about $64 
million.

                 Table 16--One-Time Implementation Costs
------------------------------------------------------------------------
                                                             Number of
                      Provider type                          affected
                                                             providers
------------------------------------------------------------------------
Religious Nonmedical Health Care Institutions...........              18
Ambulatory Surgical Centers and hospital outpatient.....          10,587
Hospices................................................           4,602
Hospitals...............................................           5,031
Transplant programs.....................................             750
Home Health Agencies....................................          12,624
Critical Access Hospitals...............................           1,343
Comprehensive Outpatient Rehabilitation Facilities......             188
Community Mental Health Centers.........................              52
Portable X-Ray Services.................................             500
Rural Health Clinics and Federally Qualified Health               12,034
 Centers................................................
Emergency Preparedness of Providers and Suppliers.......          74,246
                                                         ---------------
Total Number of Providers...............................         122,180
Average Cost Per Provider...............................            $522
                                                         ---------------
    Total One-Time Cost.................................     $63,777,960
------------------------------------------------------------------------

13. Effects on Small Entities, Effects on Small Rural Hospitals, 
Unfunded Mandates, and Federalism
    The RFA requires agencies to analyze options for regulatory relief 
of small entities, if a rule has a significant impact on a substantial 
number of small entities. For purposes of the RFA, we estimate that 
almost all health care providers regulated by CMS are small entities as 
that term is used in the RFA (including small businesses, nonprofit 
organizations, and small governmental jurisdictions). The great 
majority of hospitals and most other health care providers and 
suppliers are small entities, either by being nonprofit organizations 
or by meeting the SBA definition of a small business (having revenues 
of less than $7.5 million to $38.5 million in any 1 year, varying by 
type of provider and highest for hospitals). Accordingly, almost all of 
the savings that this proposed rule would create will benefit small 
entities. We note that individual persons are not small entities for 
purposes of the RFA, and hence the life-extending transplantation 
benefits of the proposed rule are not relevant to the RFA.
    The RFA requires that a Regulatory Flexibility Analysis (RFA) be 
prepared if a proposed rule would have a ``significant impact on a 
substantial number'' of such entities. HHS interprets the statute as 
mandating this analysis only the impact is adverse, though there are 
differing interpretations. Regardless, there is no question that this 
proposed rule would affect a ``substantial number'' of small entities. 
As shown in Table 17, the total number of affected entities will be 
about 122,000, including those affected by more than one provision. The 
rule of thumb used by HHS for determining whether an impact is 
``significant'' is an effect of 3 percent or more of annual revenues. 
These savings do not approach that threshold. Hospitals account for 
about one-third of all health care spending and even if all these 
savings accrued to hospitals this threshold would not be approached. 
Therefore, the Secretary has determined that this proposed rule will 
not have a significant economic impact on a substantial number of small 
entities.
    In addition, section 1102(b) of the Social Security Act requires us 
to prepare a regulatory impact analysis if a rule may have a 
significant impact on the operations of a substantial number of small 
rural hospitals. This analysis must conform to the provisions of 
section 603 of the RFA. For purposes of section 1102(b) of the Act, we 
define a small rural hospital as a hospital that is located outside of 
a metropolitan statistical area and has fewer than 100 beds. For the 
reasons previously given, the Secretary has determined that this 
proposed rule will not have a significant impact on the operations of a 
substantial number of small rural hospitals.
    Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) also 
requires that agencies assess anticipated costs and benefits before 
issuing any rule whose mandates require spending in any 1 year of $100 
million in 1995 dollars, updated annually for inflation. In 2018, that 
threshold is approximately $148 million. This proposed rule contains no 
mandates that will impose spending costs on State, local, or tribal 
governments, or on the private sector. Indeed, it substantially reduces 
existing private sector mandates.
    Executive Order 13132 establishes certain requirements that an 
agency must meet when it promulgates a proposed rule (and subsequent 
final rule) that imposes substantial direct requirement costs on State 
and local governments, preempts State law, or otherwise has federalism 
implications. This proposed rule imposes no such requirements. 
Importantly, it would remove Federal requirements setting qualification 
standards for hospice aides. Setting qualifications for health care 
workers is traditionally a State function, and this change would 
therefore remove an infringement on State prerogatives.
14. Effects on Costs to Facilities, Providers, Medicare, Other 
Insurance, and Patients
    Most of the individual proposals addressed in the preceding 
analysis involve reducing burdensome costs on facilities, health care 
professionals, and patients. Most of those reductions save time and 
effort currently performed on tasks that we propose to eliminate or 
reform and those reductions will result ultimately in reduced medical 
care costs in these facilities, some of which will result in further 
effects on public and private insurance costs. In this regard, it is 
important to emphasize that the CoPs and CfCs generally apply to all 
patients served by a Medicare and/or Medicaid participating provider or 
supplier, not just Medicare or Medicaid patients, and

[[Page 47744]]

to the entire operations of the provider. Revisions to those 
requirements apply broadly to the entire health care system. We are 
hopeful that cost reductions ultimately flow to reductions in charges, 
to reductions in third party payments, and hence to reductions in 
insurance costs and to those who pay those costs.
    In total, we estimate that the approximately 40 specific provisions 
summarized in Tables 1 and 2 that are not related to reductions in pre-
operative physical examinations and tests in outpatient surgery, or to 
transplantation, will save facilities and other providers, insurers, 
and patients about $669 million annually. The initial savings will 
accrue primarily to providers. How much of these savings will flow to 
insurers and patients depends primarily on the payment and 
reimbursement mechanisms in place for each affected entity for those 
particular costs. According to the National Health Expenditure 
Accounts, approximate payer shares in 2016 were 11 percent for consumer 
out of pocket, 35 percent for private health insurance, 21 percent for 
Medicare, 18 percent for Medicaid, and 15 percent for other public and 
private payers such as the Department of Veteran Affairs and the 
Department of Defense. We would expect savings to approximate these 
shares. Ultimately, all costs are paid by workers and taxpayers who pay 
for all health care directly or indirectly, quite apart from immediate 
cost subsidies or cost sharing.
    Two provisions directly reduce Medicare and other insurance costs. 
Eliminating unnecessary patient history and physical examinations and 
medical tests for procedures (such as cataract surgery) performed in 
ASCs and in hospital outpatient surgery will disproportionately reduce 
Medicare costs, since use of these services rises with age. Additional 
transplantation of kidneys will reduce Medicare's ESRD costs, partially 
offset by increased transplantation costs. Because of the difficulty in 
finding evidence of the volume of such savings, we cannot estimate the 
likely effects on Medicare spending.
    Most of the facility and provider savings will accrue to Medicare 
and other insurers over time as payment rate increases are slightly 
reduced, and the remainder will accrue to other payers and to patients.
    The following table shows our estimates of savings by major burden 
reduction category and by type of payer.

                                   Table 17--Savings by Major Payer Categories
                                                  [$ Millions]
----------------------------------------------------------------------------------------------------------------
                                          Ambulatory                              All other cost
              Savings to:                   surgery        Transplant programs      reductions         Total
----------------------------------------------------------------------------------------------------------------
Medicare..............................             123  not estimated...........             141             264
Medicaid..............................              57  not estimated...........             120             177
Private Insurance.....................             110  not estimated...........             234             344
Other Payers..........................              47  not estimated...........             100             147
Patients..............................             117  not estimated...........              74             191
                                       -------------------------------------------------------------------------
    Total.............................             454  not estimated...........             669           1,123
----------------------------------------------------------------------------------------------------------------
Note: Calculations based largely on payer percentages in ``National Health Care Spending in 2016,'' Health
  Affairs, January 2018, pages 150-160. Patient share for ambulatory surgery savings reflects travel time, not
  medical costs.

15. Benefits to Patients
    We discussed life-extending and life-saving benefits at length in 
the analysis of increases in transplantation. These result from removal 
of disincentives to transplant patients, or to use organs, where this 
could reduce success rates by a few percent and possibly trigger 
closure of transplant centers or programs under current rules. As 
previously explained, we do not have robust estimates. There are 
additional and substantial patient benefits likely to result from the 
cost-reducing reforms that we propose. Time not wasted by medical care 
providers or facilities on unnecessary tasks is time that can be used 
to focus on better care. While such effects could be measured in 
principal, there is little existing data on magnitudes of such effects. 
We do, however, welcome public comments on these or any other aspects 
of costs and benefits of the proposed rule.

D. Alternatives Considered

    From within the entire body of CoPs and CfCs, we selected what we 
believe to be the most viable candidates for reform as identified by 
stakeholders, by recent research, or by experts as unusually 
burdensome. This subset of the universe of standards is the focus of 
this proposed rule. For all of the proposed provisions, we considered 
not making these changes. Ultimately, we saw no good reasons not to 
propose these burden reducing changes.
    We welcome comments on whether we properly selected the best 
candidates for change, and welcome suggestions for additional reform 
candidates from the entire body of CoPs and other regulatory provisions 
that fall directly on providers.

E. Uncertainty

    Our estimates of the effects of this regulation are subject to 
significant uncertainty. While the Department is confident that these 
reforms will provide flexibilities to facilities that will yield major 
cost savings, there are uncertainties about the magnitude of these 
effects. Despite these uncertainties, we are confident that the rule 
will yield substantial overall cost reductions and other benefits. In 
this analysis we have provided estimates to suggest the potential 
savings these reforms could achieve under certain assumptions. We 
appreciate that those assumptions are simplified, and that actual 
results could be substantially higher or lower. Although there is 
uncertainty concerning the magnitude of all of our estimates, we do not 
have the data to provide specific estimates for each reform proposed, 
as to the range of possibilities, or to estimate all categories of 
possible benefits, including health effects.

F. Accounting Statement and Table

    As required by OMB Circular A-4 (available at https://obamawhitehouse.archives.gov/omb/circulars_a004_a-4/), in Table 18, we 
have prepared an accounting statement showing the classification of the 
transfers and costs associated with the various provisions of this 
proposed rule.
    While most provisions of the proposed rule have clearly predictable 
effects we do not in most cases have detailed empirical information on 
the precise magnitude of efforts involved (for example, time spent in 
meeting paperwork or other administrative tasks

[[Page 47745]]

that apply to a particular provider type). Other provisions (notably 
those related to organ transplantation and removal of strict H & P 
requirements before ambulatory surgery) have even more uncertain effect 
sizes. Therefore, we have estimated an upper and lower level for 
benefit and cost reduction estimates that is 25 percent higher or lower 
than our primary estimate for all quantified reforms other than those 
related to ambulatory surgery, and in that area our lower bound is zero 
cost reductions and our upper bound is a 50% reduction in H&P and 
associated laboratory testing costs.

                                    Table 18--Accounting Statement: Classification of Estimated Benefits and Savings
                                                                      [$ Millions]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                      Units
                                                   Primary                             -----------------------------------------------------------------
                    Category                       estimate   Lower bound  Upper bound      Year       Discount
                                                                                          dollars      rate (%)               Period covered
--------------------------------------------------------------------------------------------------------------------------------------------------------
Life-Extending Benefits (monetized)............                                               Not Quantified
                                                --------------------------------------------------------------------------------------------------------
Medical Cost Reduction Benefits (monetized)....                                               Not Quantified
                                                --------------------------------------------------------------------------------------------------------
Other Cost Reductions (monetized)..............      -$1,240        -$580      -$1,890         2016            7  2018 onward.
                                                     -$1,250        -$590      -$1,900         2016            3  2018 onward.
                                                --------------------------------------------------------------------------------------------------------
Costs..........................................                                                    None
                                                --------------------------------------------------------------------------------------------------------
Transfers......................................                                                    None
--------------------------------------------------------------------------------------------------------------------------------------------------------

G. Reducing Regulation and Controlling Regulatory Costs

    Executive Order 13771, titled Reducing Regulation and Controlling 
Regulatory Costs, was issued on January 30, 2017 and requires that the 
costs associated with significant new regulations ``shall, to the 
extent permitted by law, be offset by the elimination of existing costs 
associated with at least two prior regulations.'' This proposed rule 
will, if finalized as proposed, be considered an E.O. 13771 
deregulatory action. We estimate that this rule generates $1,051 
million in annualized cost savings, discounted at 7 percent relative to 
year 2018, over a perpetual time horizon. This estimate is based on 
cost reductions starting at $1,123 million, and growing by $31 million 
annually due to salary savings from X-ray technician turnover, 
partially offset by one-time first-year implementation costs of $64 
million, all in 2016 dollars. Details on the estimated cost savings 
from this rule can be found in the preceding analysis. We note that 
public comments and additional information may enable us to estimate 
considerably larger savings from reforming H & P requirements for 
ambulatory surgery or to narrow the uncertainty within the range of the 
preliminary estimates.

H. Conclusion

    This proposed rule would substantially reduce existing regulatory 
requirements imposed on health care providers through the CoPs and 
related regulatory provisions that Medicare and Medicaid providers must 
meet. For some provisions, health benefits to patients will be 
substantial and direct. Other provisions will free up time and efforts 
of health care providers to focus on improving health care quality and 
service delivery. Although this proposed rule does not require an 
Initial Regulatory Flexibility Analysis, this regulatory impact 
analysis, together with the remainder of this preamble, meets the 
requirements for such an analysis. Furthermore, the analysis in this 
section of the preamble, together with the remainder of this preamble, 
provides a complete Regulatory Impact Analysis.
    In accordance with the provisions of Executive Order 12866, this 
regulation was reviewed by the Office of Management and Budget.

List of Subjects

42 CFR Part 403

    Grant programs--health, Health insurance, Hospitals, 
Intergovernmental relations, Medicare, Reporting and recordkeeping 
requirements.

42 CFR Part 416

    Health facilities, Health professions, Medicare, Reporting and 
recordkeeping requirements.

42 CFR Part 418

    Health facilities, Hospice care, Medicare, Reporting and 
recordkeeping requirements.

42 CFR Part 441

    Aged, Family planning, Grant programs-health, Infants and children, 
Medicaid, Penalties, reporting and recordkeeping requirements.

42 CFR Part 460

    Aged, Health care, Health records, Medicaid, Medicare, Reporting 
and recordkeeping requirements.

42 CFR Part 482

    Grant program--health, Hospitals, Medicaid, Medicare, Reporting and 
recordkeeping requirements.

42 CFR Part 483

    Grant programs--health, Health facilities, Health professions, 
Health records, Medicaid, Medicare, Nursing home, Nutrition, Reporting 
and recordkeeping requirements, Safety.

42 CFR Part 484

    Health facilities, Health professions, Medicare, Reporting and 
recordkeeping requirements.

42 CFR Part 485

    Grant programs--health, Health facilities, Medicaid, Reporting and 
recordkeeping requirements.

42 CFR Part 486

    Grant programs--health, Health facilities, Medicare, Reporting and 
recordkeeping requirements, X-rays.

42 CFR Part 488

    Administrative practice and procedures, Health facilities, Health 
professions, Medicare, reporting and recordkeeping requirements.

42 CFR Part 491

    Grant programs--health, Health facilities, Medicaid, Medicare,

[[Page 47746]]

Reporting and recordkeeping requirements, Rural and Urban areas.

42 CFR Part 494

    Health facilities, Diseases, Medicare, Reporting and recordkeeping 
requirements.

    For the reasons set forth in the preamble, the Centers for Medicare 
& Medicaid Services proposes to amend 42 CFR chapter IV as set forth 
below:

PART 403--SPECIAL PROGRAMS AND PROJECTS

0
1. The authority citation for part 403 continues to read as follows:

    Authority: 42 U.S.C. 1395b-3 and Secs. 1102 and 1871 of the 
Social Security Act (42 U.S.C. 1302 and 1395hh).

0
2. Section 403.736 is amended by--
0
a. Removing the introductory text;
0
b. Revising paragraph (a);
0
c. Removing paragraph (b); and
0
d. Redesignating paragraphs (c) and (d) as paragraphs (b) and (c).
    The revision reads as follows:


Sec.  403.736  Condition of participation: Discharge planning.

    (a) Discharge planning and instructions. The RNHCI must have in 
effect a discharge planning process that applies to all patients. The 
process must assure that appropriate post-institution services are 
obtained for each patient, as necessary. The RNHCI must assess the need 
for a discharge plan for any patient likely to suffer adverse 
consequences if there is no planning.
    (1) Discharge instructions must be provided at the time of 
discharge to the patient or the patient's caregiver as necessary.
    (2) If the patient assessment indicates a need for a discharge 
plan, the discharge plan must include instructions on post-RNHCI care 
to be used by the patient or the caregiver in the patient's home, as 
identified in the discharge plan.
    (3) If the RNHCI's patient assessment does not indicate a need for 
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.
* * * * *
0
3. Section 403.748 is amended by--
0
a. Revising paragraphs (a) introductory text, (a)(4), (b) introductory 
text, (c) introductory text, (d) introductory text, and (d)(1)(ii); and
0
b. Adding paragraph (d)(1)(v).
    The revisions and addition read as follows:


Sec.  403.748  Condition of participation: Emergency preparedness.

* * * * *
    (a) Emergency plan. The RNHCI must develop and maintain an 
emergency preparedness plan that must be reviewed, and updated at least 
every 2 years. The plan must do all of the following:
* * * * *
    (4) 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.
    (b) Policies and procedures. The RNHCI must develop and implement 
emergency preparedness policies and procedures, based on the emergency 
plan set forth in paragraph (a) of this section, risk assessment at 
paragraph (a)(1) of this section, and the communication plan at 
paragraph (c) of this section. The policies and procedures must be 
reviewed and updated at least every 2 years. At a minimum, the policies 
and procedures must address the following:
* * * * *
    (c) Communication plan. The RNHCI must develop and maintain an 
emergency preparedness communication plan that complies with Federal, 
State, and local laws and must be reviewed and updated at least every 2 
years. The communication plan must include all of the following:
* * * * *
    (d) Training and testing. The RNHCI must develop and maintain an 
emergency preparedness training and testing program that is based on 
the emergency plan set forth in paragraph (a) of this section, risk 
assessment at paragraph (a)(1) of this section, policies and procedures 
at paragraph (b) of this section, and the communication plan at 
paragraph (c) of this section. The training and testing program must be 
reviewed and updated at least every 2 years.
    (1) * * *
    (ii) Provide emergency preparedness training at least every 2 
years.
* * * * *
    (v) If the emergency preparedness policies and procedures are 
significantly updated, the RNHCI must conduct training on the updated 
policies and procedures.
* * * * *

PART 416--AMBULATORY SURGICAL SERVICES

0
4. The authority citation for part 416 continues to read as follows:

    Authority: Secs. 1102, 1138, and 1871 of the Social Security Act 
(42 U.S.C. 1302, 1320-8, and 1395hh) and section 371 of the Public 
Health Service Act (42 U.S.C. 273)).


Sec.  416.41  [Amended]

0
5. Section 416.41 is amended by removing paragraph (b)(3).
0
6. Section 416.47 is amended by revising paragraph (b)(2) to read as 
follows:


Sec.  416.47  Condition for coverage--Medical records.

* * * * *
    (b) * * *
    (2) Significant medical history and results of physical examination 
(as applicable).
* * * * *
0
7. Section 416.52 is amended by revising the section heading and 
paragraph (a) to read as follows:


Sec.  416.52   Condition for coverage--Patient admission, assessment 
and discharge.

* * * * *
    (a) Standard: Patient assessment and admission. (1) The ASC must 
develop and maintain a policy that identifies those patients who 
require a medical history and physical examination prior to surgery. 
The policy must--
    (i) Include the timeframe for medical history and physical 
examination to be completed prior to surgery.
    (ii) Address, but is not limited to, the following factors: Patient 
age, diagnosis, the type and number of procedures scheduled to be 
performed on the same surgery date, known comorbidities, and the 
planned anesthesia level.
    (iii) Follow nationally recognized standards of practice and 
guidelines, and applicable State and local health and safety laws.
    (2) Upon admission, each patient must have a pre-surgical 
assessment completed by a physician who will be performing the surgery 
or other qualified practitioner in accordance with applicable State 
health and safety laws, standards of practice, and ASC policy.
    (3) The pre-surgical assessment must include documentation of any 
allergies to drugs and biologicals.
    (4) The patient's medical history and physical examination (if any) 
must be placed in the patient's medical record prior to the surgical 
procedure.
* * * * *
0
8. Section 416.54 is amended by--
0
a. Revising paragraphs (a) introductory text, (a)(4), (b) introductory 
text, (c) introductory text, (d) introductory text, and (d)(1)(ii);
0
b. Adding paragraph (d)(1)(v); and
0
c. Revising paragraph (d)(2).

[[Page 47747]]

    The revisions and addition read as follows:


Sec.  416.54  Condition for coverage--Emergency preparedness.

* * * * *
    (a) Emergency plan. The ASC must develop and maintain an emergency 
preparedness plan that must be reviewed, and updated at least every 2 
years. The plan must do the following:
* * * * *
    (4) 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.
    (b) Policies and procedures. The ASC must develop and implement 
emergency preparedness policies and procedures, based on the emergency 
plan set forth in paragraph (a) of this section, risk assessment at 
paragraph (a)(1) of this section, and the communication plan at 
paragraph (c) of this section. The policies and procedures must be 
reviewed and updated at least every 2 years. At a minimum, the policies 
and procedures must address the following:
* * * * *
    (c) Communication plan. The ASC must develop and maintain an 
emergency preparedness communication plan that complies with Federal, 
State, and local laws and must be reviewed and updated at least every 2 
years. The communication plan must include all of the following:
* * * * *
    (d) Training and testing. The ASC must develop and maintain an 
emergency preparedness training and testing program that is based on 
the emergency plan set forth in paragraph (a) of this section, risk 
assessment at paragraph (a)(1) of this section, policies and procedures 
at paragraph (b) of this section, and the communication plan at 
paragraph (c) of this section. The training and testing program must be 
reviewed and updated at least every 2 years.
    (1) * * *
    (ii) Provide emergency preparedness training at least every 2 
years.
* * * * *
    (v) If the emergency preparedness policies and procedures are 
significantly updated, the ASC must conduct training on the updated 
policies and procedures.
    (2) Testing. The ASC must conduct exercises to test the emergency 
plan at least annually. The ASC must do the following:
    (i) Participate in a full-scale exercise that is community-based or 
when a community-based exercise is not accessible, individual, a 
facility-based functional exercise every 2 years. If the ASC 
experiences an actual natural or man-made emergency that requires 
activation of the emergency plan, the ASC is exempt from engaging in 
its next required community-based or individual, facility-based 
functional exercise following the onset of the actual event.
    (ii) Conduct an additional exercise at least every 2 years, 
opposite the year the full-scale or functional exercise under paragraph 
(d)(2)(i) of this section is conducted, that may include, but is not 
limited to the following:
    (A) A second full-scale exercise that is community-based, or an 
individual, facility-based functional exercise; or
    (B) A mock disaster drill; or
    (C) A tabletop exercise or workshop that includes a group 
discussion led by a facilitator, using a narrated, clinically-relevant 
emergency scenario, and a set of problem statements, directed messages, 
or prepared questions designed to challenge an emergency plan.
    (iii) Analyze the ASC's response to and maintain documentation of 
all drills, tabletop exercises, and emergency events and revise the 
ASC's emergency plan, as needed.
* * * * *

PART 418--HOSPICE CARE

0
9. The authority citation for part 418 continues to read as follows:

    Authority: Secs. 1102 and 1871 of the Social Security Act (42 
U.S.C. 1302 and 1395hh).

0
10. Section 418.76 is amended by revising paragraph (a)(1)(iv) to read 
as follows:


Sec.  418.76  Condition of participation: Hospice aide and homemaker 
services.

* * * * *
    (a) * * *
    (1) * * *
    (iv) A State licensure program.
* * * * *
0
11. Section 418.106 is amended by--
0
a. Removing paragraph (a)(1);
0
b. Redesignating paragraph (a)(2) as paragraph (a)(1);
0
c. Adding a new reserved paragraph (a)(2); and
0
d. Revising paragraph (e)(2)(i).
    The revision reads as follows:


Sec.  418.106  Condition of participation: Drugs and biologicals, 
medical supplies, and durable medical equipment.

* * * * *
    (a) * * *
    (2) [Reserved]
* * * * *
    (e) * * *
    (2) * * *
    (i) Safe use and disposal of controlled drugs in the patient's 
home. The hospice must have written policies and procedures for the 
management, use, storage, and disposal of controlled drugs in the 
patient's home. At the time when controlled drugs are first ordered the 
hospice must:
    (A) Provide information regarding the use, storage, and disposal of 
controlled drugs to the patient or patient representative and family in 
a format that is available on a continual basis;
    (B) 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; and
    (C) Document in the patient's clinical record that the information 
was provided and discussed.
* * * * *
0
12. Section 418.112 is amended by adding paragraph (c)(10) and removing 
paragraph (f) to read as follows:


Sec.  418.112  Condition of participation: Hospices that provide 
hospice care to residents of a SNF/NF or ICF/IID.

* * * * *
    (c) * * *
    (10) A delineation of responsibilities for assuring orientation of 
SNF/NF or ICF/IID staff furnishing care to hospice patients, to include 
information regarding the hospice philosophy; hospice policies and 
procedures regarding methods of comfort, pain control, and symptom 
management; principles about death, dying, and individual responses to 
death; patient rights; appropriate forms; and record keeping 
requirements.
* * * * *
0
13. Section 418.113 is amended by--
0
a. Revising paragraphs (a) introductory text, (a)(4), (b) introductory 
text, (c) introductory text, (d) introductory text, and (d)(1)(iii);
0
b. Adding paragraph (d)(1)(vi);
0
c. Revising paragraph (d)(2); and
0
d. Adding paragraph (d)(3).
    The revisions and addition to read as follows:


Sec.  418.113  Condition of participation: Emergency preparedness.

* * * * *
    (a) Emergency plan. The hospice must develop and maintain an 
emergency preparedness plan that must be reviewed, and updated at least 
every 2 years. The plan must do the following:
* * * * *
    (4) Include a process for cooperation and collaboration with local, 
tribal,

[[Page 47748]]

regional, State, or Federal emergency preparedness officials' efforts 
to maintain an integrated response during a disaster or emergency 
situation.
    (b) Policies and procedures. The hospice must develop and implement 
emergency preparedness policies and procedures, based on the emergency 
plan set forth in paragraph (a) of this section, risk assessment at 
paragraph (a)(1) of this section, and the communication plan at 
paragraph (c) of this section. The policies and procedures must be 
reviewed and updated at least every 2 years. At a minimum, the policies 
and procedures must address the following:
* * * * *
    (c) Communication plan. The hospice must develop and maintain an 
emergency preparedness communication plan that complies with Federal, 
State, and local laws and must be reviewed and updated at least every 2 
years. The communication plan must include all of the following:
* * * * *
    (d) Training and testing. The hospice must develop and maintain an 
emergency preparedness training and testing program that is based on 
the emergency plan set forth in paragraph (a) of this section, risk 
assessment at paragraph (a)(1) of this section, policies and procedures 
at paragraph (b) of this section, and the communication plan at 
paragraph (c) of this section. The training and testing program must be 
reviewed and updated at least every 2 years.
    (1) * * *
    (iii) Provide emergency preparedness training at least every 2 
years.
* * * * *
    (vi) If the emergency preparedness policies and procedures are 
significantly updated, the hospice must conduct training on the updated 
policies and procedures.
    (2) Testing for hospices that provide care in the patient's home. 
The hospice must conduct exercises to test the emergency plan at least 
annually. The hospice must do the following:
    (i) Participate in a full-scale exercise that is community-based or 
when a community-based exercise is not accessible, an individual, 
facility-based functional exercise every 2 years. If the hospice 
experiences an actual natural or man-made emergency that requires 
activation of the emergency plan, the hospital is exempt from engaging 
in its next required full-scale community-based or individual, 
facility-based functional exercise following the onset of the actual 
event.
    (ii) Conduct an additional exercise at least every 2 years, 
opposite the year the full-scale or functional exercise under paragraph 
(d)(2)(i) of this section is conducted, that may include, but is not 
limited to the following:
    (A) A second full-scale exercise that is community-based or an 
individual, facility-based functional exercise; or
    (B) A mock disaster drill; or
    (C) A tabletop exercise or workshop that includes a group 
discussion led by a facilitator, using a narrated, clinically-relevant 
emergency scenario, and a set of problem statements, directed messages, 
or prepared questions designed to challenge an emergency plan.
    (3) Testing for hospices that provide inpatient care directly. The 
hospice must conduct exercises to test the emergency plan twice per 
year. The hospice must do the following:
    (i) Participate in a full-scale exercise that is community-based or 
when a community-based exercise is not accessible, an individual, 
facility-based functional exercise annually. If the hospice experiences 
an actual natural or man-made emergency that requires activation of the 
emergency plan, the hospice is exempt from engaging in its next 
required full-scale community-based or individual, facility-based 
functional exercise following the onset of the actual event.
    (ii) Conduct an additional exercise at least annually that may 
include, but is not limited to the following:
    (A) A second full-scale exercise that is community-based or an 
individual, facility-based functional exercise; or
    (B) A mock disaster drill; or
    (C) A tabletop exercise or workshop that includes a group 
discussion led by a facilitator, using a narrated, clinically-relevant 
emergency scenario, and a set of problem statements, directed messages, 
or prepared questions designed to challenge an emergency plan.
    (iii) Analyze the hospice's response to and maintain documentation 
of all drills, tabletop exercises, and emergency events and revise the 
hospice's emergency plan, as needed.
* * * * *

PART 441--SERVICES: REQUIREMENTS AND LIMITS APPLICABLE TO SPECIFIC 
SERVICES

0
14. The authority citation for part 441 continues to read as follows:

    Authority: Secs. 1102, 1902, and 1928 of the Social Security Act 
(42 U.S.C. 1302).

0
15. Section 441.184 is amended by--
0
a. Revising paragraphs (a) introductory text, (a)(4), (b) introductory 
text, (c) introductory text, (d) introductory text, and (d)(1)(ii);
0
b. Adding paragraph (d)(1)(v); and
0
c. Revising paragraph (d)(2).
    The revisions and addition read as follows:


Sec.  441.184   Emergency preparedness.

* * * * *
    (a) Emergency plan. The PRTF must develop and maintain an emergency 
preparedness plan that must be reviewed, and updated at least every 2 
years. The plan must do the following:
* * * * *
    (4) 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.
    (b) Policies and procedures. The PRTF must develop and implement 
emergency preparedness policies and procedures, based on the emergency 
plan set forth in paragraph (a) of this section, risk assessment at 
paragraph (a)(1) of this section, and the communication plan at 
paragraph (c) of this section. The policies and procedures must be 
reviewed and updated at least every 2 years. At a minimum, the policies 
and procedures must address the following:
* * * * *
    (c) Communication plan. The PRTF must develop and maintain an 
emergency preparedness communication plan that complies with Federal, 
State, and local laws and must be reviewed and updated at least every 2 
years. The communication plan must include all of the following:
* * * * *
    (d) Training and testing. The PRTF must develop and maintain an 
emergency preparedness training program that is based on the emergency 
plan set forth in paragraph (a) of this section, risk assessment at 
paragraph (a)(1) of this section, policies and procedures at paragraph 
(b) of this section, and the communication plan at paragraph (c) of 
this section. The training and testing program must be reviewed and 
updated at least every 2 years.
    (1) * * *
    (ii) After initial training, provide emergency preparedness 
training every 2 years.
* * * * *
    (v) If the emergency preparedness policies and procedures are 
significantly updated, the PRTF must conduct training on the updated 
policies and procedures.
    (2) Testing. The PRTF must conduct exercises to test the emergency 
plan

[[Page 47749]]

twice per year. The PRTF must do the following:
    (i) Participate in a full-scale exercise annually that is 
community-based or when a community-based exercise is not accessible, 
an individual, facility-based functional exercise annually. If the PRTF 
experiences an actual natural or man-made emergency that requires 
activation of the emergency plan, the PRTF is exempt from engaging in 
its next required full-scale community-based or individual, facility-
based functional exercise following the onset of the actual event.
    (ii) Conduct an additional exercise at least annually that may 
include, but is not limited to the following:
    (A) A second full-scale exercise that is community-based or 
individual, a facility-based functional exercise; or
    (B) A mock disaster drill; or
    (C) A tabletop exercise or workshop that includes a group 
discussion led by a facilitator, using a narrated, clinically-relevant 
emergency scenario, and a set of problem statements, directed messages, 
or prepared questions designed to challenge an emergency plan.
    (iii) Analyze the PRTF's response to and maintain documentation of 
all drills, tabletop exercises, and emergency events and revise the 
PRTF's emergency plan, as needed.
* * * * *

PART 460--PROGRAMS OF ALL-INCLUSIVE CARE FOR THE ELDERLY (PACE)

0
16. The authority citation for part 460 continues to read as follows:

    Authority: Secs: 1102, 1871, 1894(f), and 1934(f) of the Social 
Security Act (42 U.S.C. 1302, 1395, 1395eee(f), and 1396u-4(f)).

0
17. Section 460.84 is amended by--
0
a. Revising paragraphs (a) introductory text, (a)(4), (b) introductory 
text, (c) introductory text, (d) introductory text, and (d)(1)(ii);
0
b. Adding paragraph (d)(1)(v); and
0
c. Revising paragraph (d)(2).
    The revisions and addition read as follows:


Sec.  460.84  Emergency preparedness.

* * * * *
    (a) Emergency plan. The PACE organization must develop and maintain 
an emergency preparedness plan that must be reviewed, and updated at 
least every 2 years. The plan must do the following:
* * * * *
    (4) 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.
    (b) Policies and procedures. The PACE organization must develop and 
implement emergency preparedness policies and procedures, based on the 
emergency plan set forth in paragraph (a) of this section, risk 
assessment at paragraph (a)(1) of this section, and the communication 
plan at paragraph (c) of this section. The policies and procedures must 
address management of medical and nonmedical emergencies, including, 
but not limited to: Fire; equipment, power, or water failure; care-
related emergencies; and natural disasters likely to threaten the 
health or safety of the participants, staff, or the public. Policies 
and procedures must be reviewed and updated at least every 2 years. At 
a minimum, the policies and procedures must address the following:
* * * * *
    (c) Communication plan. The PACE organization must develop and 
maintain an emergency preparedness communication plan that complies 
with Federal, State, and local laws and must be reviewed and updated at 
least every 2 years. The communication plan must include all of the 
following:
* * * * *
    (d) Training and testing. The PACE organization must develop and 
maintain an emergency preparedness training and testing program that is 
based on the emergency plan set forth in paragraph (a) of this section, 
risk assessment at paragraph (a)(1) of this section, policies and 
procedures at paragraph (b) of this section, and the communication plan 
at paragraph (c) of this section. The training and testing program must 
be reviewed and updated at lease every 2 years.
    (1) * * *
    (ii) Provide emergency preparedness training at least every 2 
years.
* * * * *
    (v) If the emergency preparedness policies and procedures are 
significantly updated, the PACE must conduct training on the updated 
policies and procedures.
    (2) Testing. The PACE organization must conduct exercises to test 
the emergency plan at least annually. The PACE organization must do the 
following:
    (i) Participate in a full-scale exercise that is community-based or 
when a community-based exercise is not accessible, an individual, 
facility-based functional exercise every 2 years. If the PACE 
experiences an actual natural or man-made emergency that requires 
activation of the emergency plan, the PACE is exempt from engaging in 
its next required full-scale community-based or individual, facility-
based functional exercise following the onset of the actual event.
    (ii) Conduct an additional exercise at least every 2 years opposite 
the year the full-scale or functional exercise under paragraph 
(d)(2)(i) of this section is conducted that may include, but is not 
limited to the following:
    (A) A second full-scale exercise that is community-based or an 
individual, facility-based functional exercise; or
    (B) A mock disaster drill; or
    (C) A tabletop exercise or workshop that includes a group 
discussion led by a facilitator, using a narrated, clinically-relevant 
emergency scenario, and a set of problem statements, directed messages, 
or prepared questions designed to challenge an emergency plan.
    (iii) Analyze the PACE's response to and maintain documentation of 
all drills, tabletop exercises, and emergency events and revise the 
PACE's emergency plan, as needed.
* * * * *

PART 482--CONDITIONS OF PARTICIPATION FOR HOSPITALS

0
18. The authority citation for part 482 continues to read as follows:

    Authority: Secs. 1102, 1871, and 1881 of the Social Security Act 
(42 U.S.C. 1302, 1395hh, and 1395rr), unless otherwise noted.

0
19. Section 482.15 is amended--
0
a. By revising paragraphs (a) introductory text, (a)(4), (b) 
introductory text, (c) introductory text, (d) introductory text, and 
(d)(1)(ii);
0
b. By adding paragraph (d)(1)(v);
0
c. By revising paragraph (d)(2);
0
d. In paragraph (g) introductory text, by removing the phrase 
``transplant centers'' and adding into its place the phrase 
``transplant programs''; and
0
e. In paragraphs (g)(1) and (2), by removing the phrase ``transplant 
center'' and adding into its place the phrase ``transplant program''.
    The revisions and addition read as follows:


Sec.  482.15  Condition of participation: Emergency preparedness.

* * * * *
    (a) Emergency plan. The hospital must develop and maintain an 
emergency preparedness plan that must be reviewed, and updated at least 
every 2 years. The plan must do the following:
* * * * *
    (4) Include a process for cooperation and collaboration with local, 
tribal, regional, State, and Federal emergency preparedness officials' 
efforts to

[[Page 47750]]

maintain an integrated response during a disaster or emergency 
situation.
    (b) Policies and procedures. The hospital must develop and 
implement emergency preparedness policies and procedures, based on the 
emergency plan set forth in paragraph (a) of this section, risk 
assessment at paragraph (a)(1) of this section, and the communication 
plan at paragraph (c) of this section. The policies and procedures must 
be reviewed and updated at least every 2 years. At a minimum, the 
policies and procedures must address the following:
* * * * *
    (c) Communication plan. The hospital must develop and maintain an 
emergency preparedness communication plan that complies with Federal, 
State, and local laws and must be reviewed and updated at least every 2 
years. The communication plan must include all of the following:
* * * * *
    (d) Training and testing. The hospital must develop and maintain an 
emergency preparedness training and testing program that is based on 
the emergency plan set forth in paragraph (a) of this section, risk 
assessment at paragraph (a)(1) of this section, policies and procedures 
at paragraph (b) of this section, and the communication plan at 
paragraph (c) of this section. The training and testing program must be 
reviewed and updated at least every 2 years.
    (1) * * *
    (ii) Provide emergency preparedness training at least every 2 
years.
* * * * *
    (v) If the emergency preparedness policies and procedures are 
significantly updated, the hospital must conduct training on the 
updated policies and procedures.
    (2) Testing. The hospital must conduct exercises to test the 
emergency plan at least twice per year. The hospital must do all of the 
following:
    (i) Participate in an annual full-scale exercise that is community-
based or when a community-based exercise is not accessible, an 
individual, facility-based functional exercise annually. If the 
hospital experiences an actual natural or man-made emergency that 
requires activation of the emergency plan, the hospital is exempt from 
engaging in its next required full-scale community-based exercise or 
individual, facility-based functional exercise following the onset of 
the actual event.
    (ii) Conduct an additional exercise at least annually that may 
include, but is not limited to the following:
    (A) A second full-scale exercise that is community-based or an 
individual, facility-based functional exercise; or
    (B) A mock disaster drill; or
    (C) A tabletop exercise or workshop that includes a group 
discussion led by a facilitator, using a narrated, clinically-relevant 
emergency scenario, and a set of problem statements, directed messages, 
or prepared questions designed to challenge an emergency plan.
    (iii) Analyze the hospital's response to and maintain documentation 
of all drills, tabletop exercises, and emergency events, and revise the 
hospital's emergency plan, as needed.
* * * * *
0
20. Section 482.21 is amended by adding paragraph (f) to read as 
follows:


Sec.  482.21  Condition of participation: Quality assessment and 
performance improvement program.

* * * * *
    (f) Standard: Unified and integrated QAPI program for multi-
hospital systems. If a hospital is part of a hospital system consisting 
of multiple separately certified hospitals using a system governing 
body that is legally responsible for the conduct of two or more 
hospitals, the system governing body can elect to have a unified and 
integrated QAPI program for all of its member hospitals 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 subject to the system governing body must 
demonstrate that:
    (1) The unified and integrated QAPI 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; and
    (2) 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.
0
21. Section 482.22 is amended by--
0
a. Revising paragraphs (c)(5)(i) and (ii);
0
b. Adding paragraphs (c)(5)(iii), (iv), and (v); and
0
c. Removing paragraph (d).
    The revisions and additions read as follows:


Sec.  482.22  Condition of participation: Medical staff.

* * * * *
    (c) * * *
    (5) * * *
    (i) A medical history and physical examination 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, and except as provided under paragraph 
(c)(5)(iii) of this section. The medical history and physical 
examination 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.
    (ii) 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 medical history and physical 
examination are completed within 30 days before admission or 
registration, and except as provided under paragraph (c)(5)(iii) of 
this section. The updated examination of the patient, including any 
changes in the patient's condition, 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.
    (iii) An assessment of the patient (in lieu of the requirements of 
paragraphs (c)(5)(i) and (ii) of this section) 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) of this 
section, 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 assessment 
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.

[[Page 47751]]

    (iv) The medical staff develop and maintain a policy that 
identifies those patients for whom the assessment requirements of 
paragraph (c)(5)(iii) of this section would apply. The provisions of 
paragraphs (c)(5)(iii), (iv), and (v) of this section do not apply to a 
medical staff that chooses to maintain a policy that adheres to the 
requirements of paragraphs of (c)(5)(i) and (ii) of this section for 
all patients.
    (v) The medical staff, if it chooses to develop and maintain a 
policy for the identification of specific patients to whom the 
assessment requirements in paragraph (c)(5)(iii) of this section would 
apply, must demonstrate evidence that the policy applies only to those 
patients receiving specific outpatient surgical or procedural services 
as well as evidence that the policy is based on:
    (A) 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.
    (B) Nationally recognized guidelines and standards of practice for 
assessment of specific types of patients prior to specific outpatient 
surgeries and procedures.
    (C) Applicable state and local health and safety laws.
* * * * *
0
22. Section 482.24 is amended by revising paragraphs (c)(4)(i)(A) and 
(B) and adding paragraph (c)(4)(i)(C) to read as follows:


Sec.  482.24  Condition of participation: Medical record services.

* * * * *
    (c) * * *
    (4) * * *
    (i) * * *
    (A) A medical history and physical examination completed and 
documented no more than 30 days before or 24 hours after admission or 
registration, but prior to surgery or a procedure requiring anesthesia 
services, and except as provided under paragraph (c)(4)(i)(C) of this 
section. The medical history and physical examination must be placed in 
the patient's medical record within 24 hours after admission or 
registration, but prior to surgery or a procedure requiring anesthesia 
services.
    (B) An updated examination of the patient, including any changes in 
the patient's condition, when the medical history and physical 
examination are completed within 30 days before admission or 
registration, and except as provided under paragraph (c)(4)(i)(C) of 
this section. Documentation of the updated examination must be placed 
in the patient's medical record within 24 hours after admission or 
registration, but prior to surgery or a procedure requiring anesthesia 
services.
    (C) An assessment of the patient (in lieu of the requirements of 
paragraphs (c)(4)(i)(A) and (B) of this section) 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 Sec.  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.
* * * * *
0
23. Section 482.42 is amended by adding paragraph (c) to read as 
follows:


Sec.  482.42   Condition of participation: Infection control.

* * * * *
    (c) Standard: Unified and integrated infection control program for 
multi-hospital systems. If a hospital 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 subject to the system governing body must 
demonstrate that:
    (1) 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;
    (2) 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;
    (3) 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
    (4) A qualified individual (or individuals) with expertise in 
infection prevention and control has been designated at the hospital as 
responsible for communicating with the unified infection control 
program, for implementing and maintaining the policies and procedures 
governing infection control as directed by the unified infection 
control program, and for providing infection prevention education and 
training to hospital staff.
0
24. Section 482.51 is amended by revising paragraphs (b)(1)(i) and (ii) 
and adding paragraph (b)(1)(iii) to read as follows:


Sec.  482.51  Condition of participation: Surgical services.

* * * * *
    (b) * * *
    (1) * * *
    (i) A medical history and physical examination must be completed 
and documented no more than 30 days before or 24 hours after admission 
or registration, and except as provided under paragraph (b)(1)(iii) of 
this section.
    (ii) 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, and except as provided under paragraph (b)(1)(iii) of 
this section.
    (iii) An assessment of the patient must be completed and documented 
after registration (in lieu of the requirements of paragraphs (b)(1)(i) 
and (ii) of this section) 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 Sec.  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.
* * * * *
0
25. Section 482.58 is amended by--
0
a. Revising paragraph (b)(1);
0
b. Removing paragraph (b)(4);
0
c. Redesignating paragraphs (b)(5) through (8) as paragraphs (b)(4) 
through (7); and
0
d. Revising newly redesignated paragraphs (b)(4) and (7).
    The revisions read as follows:


Sec.  482.58  Special requirements for hospital providers of long-term 
care services (``swing-beds'').

* * * * *

[[Page 47752]]

    (b) * * *
    (1) Resident rights (Sec.  483.10(b)(7), (c)(1), (c)(2)(iii), 
(c)(6), (d), (e)(2) and (4), (f)(4)(ii) and (iii), (h), (g)(8) and 
(17), and (g)(18) introductory text of this chapter).
* * * * *
    (4) Social services (Sec.  483.40(d) of this chapter).
* * * * *
    (7) Dental services (Sec.  483.55(a)(2), (3), (4), and (5) and (b) 
of this chapter).
0
26. Section 482.61 is amended by revising paragraph (d) to read as 
follows:


Sec.  482.61   Condition of participation: Special medical record 
requirements for psychiatric hospitals.

* * * * *
    (d) Standard: Recording progress. Progress notes must be recorded 
by the physician(s), psychologists, or other licensed independent 
practitioner(s) responsible for the care of the patient as specified in 
Sec.  482.12(c), nurse, social worker and, when appropriate, others 
significantly involved in active treatment modalities. The frequency of 
progress notes is determined by the condition of the patient but must 
be recorded at least weekly for the first 2 months and at least once a 
month thereafter and must contain recommendations for revisions in the 
treatment plan as indicated as well as precise assessment of the 
patient's progress in accordance with the original or revised treatment 
plan.
* * * * *


Sec.  482.68   [Amended]

0
27. Section 482.68 is amended--
0
a. In the section heading by removing the phrase ``transplant centers'' 
and adding in its place the phrase ``transplant programs''; and
0
b. In the introductory text and in paragraph (b) by removing the phrase 
``transplant center'' and adding in its place the phrase ``transplant 
program''.
0
28. Section 482.70 is amended--
0
a. In the definition of ``Adverse event'' by removing the phrase 
``transplant centers'' and adding in its place the phrase ``transplant 
programs'';
0
b. By removing the definitions of ``Heart-Lung transplant center'' and 
``Intestine transplant center'';
0
c. By adding the definitions of ``Heart-Lung transplant program'' and 
``Intestine transplant program'' in alphabetical order;
0
d. By removing the definitions of ``Pancreas transplant center'' and 
``Transplant center'';
0
e. By adding the definition of ``Pancreas transplant program'' in 
alphabetical order; and
0
f. By revising the definition of ``Transplant program''.
    The additions and revision read as follows:


Sec.  482.70  Definitions.

* * * * *
    Heart-Lung transplant program means a transplant program that is 
located in a hospital with an existing Medicare-approved heart 
transplant program and an existing Medicare-approved lung program that 
performs combined heart-lung transplants.
    Intestine transplant program means a Medicare-approved liver 
transplant program that performs intestine transplants, combined liver-
intestine transplants, or multivisceral transplants.
* * * * *
    Pancreas transplant program means a Medicare-approved kidney 
transplant program that performs pancreas transplants alone or 
subsequent to a kidney transplant as well as kidney-pancreas 
transplants.
* * * * *
    Transplant program means an organ-specific transplant program 
within a transplant hospital (as defined in this section).


Sec. Sec.  482.72, 482.74, 482.78, and 482.80  [Amended]

0
29. In the following table, for each section and paragraph indicated in 
the first two columns, remove the phrase indicated in the third column 
each time it appears and add the reference indicated in the fourth 
column:

----------------------------------------------------------------------------------------------------------------
             Section                       Paragraphs                  Remove                      Add
----------------------------------------------------------------------------------------------------------------
Sec.   482.72....................  .........................  transplant center.......  transplant program.
Sec.   482.74....................  (a) introductory text....  transplant center.......  transplant program.
Sec.   482.74....................  (a) introductory text....  center's................  hospital's.
Sec.   482.74....................  (a)(1)...................  transplant center.......  transplant program.
Sec.   482.74....................  (a)(1)...................  center's................  program's.
Sec.   482.74....................  (a)(2)...................  transplant center.......  transplant program.
Sec.   482.74....................  (a)(3)...................  transplant center.......  transplant program.
Sec.   482.74....................  (b) introductory text....  transplant center.......  transplant program.
Sec.   482.78....................  Section heading..........  transplant centers......  transplant programs.
Sec.   482.78....................  Introductory text........  transplant center.......  transplant program.
Sec.   482.78....................  (a)......................  transplant center.......  transplant program.
Sec.   482.78....................  (b)......................  transplant center.......  transplant program.
Sec.   482.80....................  Section heading..........  transplant centers......  transplant programs.
Sec.   482.80....................  Introductory text........  transplant centers......  transplant programs.
Sec.   482.80....................  (a)......................  transplant center.......  transplant program.
Sec.   482.80....................  (a)......................  beneficiary.............  recipient.
Sec.   482.80....................  (b)......................  transplant center.......  transplant program.
Sec.   482.80....................  (c) introductory text....  center..................  program.
Sec.   482.80....................  (c)(1)...................  transplant center's.....  transplant program's.
Sec.   482.80....................  (c)(1)...................  center-specific report..  program-specific report.
Sec.   482.80....................  (c)(1)...................  Beneficiaries...........  Recipients.
Sec.   482.80....................  (c)(2)...................  center's................  program's.
Sec.   482.80....................  (d)(1)...................  transplant center.......  transplant program.
Sec.   482.80....................  (d)(2)...................  transplant center.......  transplant program.
Sec.   482.80....................  (d)(3)...................  transplant center.......  transplant program.
Sec.   482.80....................  (d)(4)...................  transplant center.......  transplant program.
Sec.   482.80....................  (d)(5)...................  transplant center.......  transplant program.
----------------------------------------------------------------------------------------------------------------


[[Page 47753]]

Sec.  482.82  [Removed]

0
30. Section 482.82 is removed.


Sec. Sec.  482.90, 482.92, 482.94, 482.96, 482.98, 482.100, and 
482.102  [Amended]

0
31. In the following table, for each section and paragraph indicated in 
the first two columns, remove the phrase indicated in the third column 
each time it appears and add the reference indicated in the fourth 
column:

----------------------------------------------------------------------------------------------------------------
             Section                       Paragraphs                  Remove                      Add
----------------------------------------------------------------------------------------------------------------
Sec.   482.90....................  Introductory text........  transplant center.......  transplant program.
Sec.   482.90....................  Introductory text........  center..................  program.
Sec.   482.90....................  (a)(2)...................  transplant center.......  transplant program.
Sec.   482.90....................  (a)(4)...................  transplant center.......  transplant program.
Sec.   482.90....................  (b) introductory text....  Transplant centers......  Transplant programs.
Sec.   482.92....................  Introductory text........  donor-beneficiary.......  donor-recipient.
Sec.   482.92....................  Introductory text........  beneficiary.............  recipient.
Sec.   482.92....................  Introductory text........  Transplant centers......  Transplant programs.
Sec.   482.92....................  Introductory text........  transplant center.......  transplant program.
Sec.   482.92....................  (a)......................  transplant center.......  transplant program.
Sec.   482.92....................  (a)......................  beneficiary.............  recipient.
Sec.   482.92....................  (b)......................  beneficiary.............  recipient.
Sec.   482.92....................  (b)......................  beneficiary's...........  recipient's.
Sec.   482.94....................  Introductory text........  Transplant centers......  Transplant programs.
Sec.   482.94....................  Introductory text........  transplant center.......  transplant programs.
Sec.   482.94....................  Introductory text........  the center also.........  the program also.
Sec.   482.94....................  (a) introductory text....  transplant center's.....  transplant program's.
Sec.   482.94....................  (a)(2)...................  center..................  program.
Sec.   482.94....................  (b) introductory text....  Transplant centers......  Transplant programs.
Sec.   482.94....................  (b)(2)...................  center's................  program's.
Sec.   482.94....................  (b)(3)...................  center's................  program's.
Sec.   482.94....................  (c) introductory text....  Transplant centers......  Transplant programs.
Sec.   482.94....................  (c) introductory text....  center's waiting list...  program's waiting list.
Sec.   482.94....................  (c)(2)...................  transplant center.......  transplant program.
Sec.   482.94....................  (c)(3) introductory text.  transplant centers......  transplant programs.
Sec.   482.94....................  (d) introductory text....  transplant center.......  transplant program.
Sec.   482.94....................  (d)(2)...................  transplant center.......  transplant program.
Sec.   482.94....................  (e)......................  Transplant centers......  Transplant programs.
Sec.   482.96....................  Introductory text........  Transplant centers......  Transplant programs.
Sec.   482.96....................  (a)......................  transplant center's.....  transplant program's.
Sec.   482.96....................  (a)......................  beneficiary.............  recipient.
Sec.   482.96....................  (a)......................  transplant center.......  transplant program.
Sec.   482.96....................  (b) introductory text....  transplant center.......  transplant program.
Sec.   482.96....................  (b)(2)...................  transplant center.......  transplant program.
Sec.   482.96....................  (b)(2)...................  transplant center's.....  transplant program's.
Sec.   482.98....................  Introductory text........  transplant center.......  transplant program.
Sec.   482.98....................  Introductory text........  the center..............  the program.
Sec.   482.98....................  (a) (a) heading and        transplant center.......  transplant program.
                                    introductory text.
Sec.   482.98....................  (a)(1)...................  transplant center.......  transplant program.
Sec.   482.98....................  (b) introductory text....  transplant center.......  transplant program.
Sec.   482.98....................  (c) introductory text....  transplant center.......  transplant program.
Sec.   482.98....................  (c)(2)...................  transplant center.......  transplant program.
Sec.   482.98....................  (d) introductory text....  transplant center.......  transplant program.
Sec.   482.98....................  (d) heading..............  living donor advocate     independent living donor
                                                               team.                     advocate team.
Sec.   482.98....................  (d)(1)...................  living donor advocate...  independent living donor
                                                                                         advocate.
Sec.   482.98....................  (d)(2) introductory text.  living donor advocate     independent living donor
                                                               team.                     advocate team.
Sec.   482.98....................  (d)(3) introductory text.  living donor advocate     independent living donor
                                                               team.                     advocate team.
Sec.   482.98....................  (e)......................  transplant center.......  transplant program.
Sec.   482.98....................  (f)......................  transplant center.......  transplant program.
Sec.   482.100...................  .........................  transplant center.......  transplant program.
Sec.   482.102...................  Introductory text........  transplant center.......  transplant program.
Sec.   482.102...................  (a) introductory text....  Transplant centers......  Transplant programs.
Sec.   482.102...................  (a)(8)...................  transplant center.......  transplant program.
Sec.   482.102...................  (a)(8)...................  beneficiary's...........  recipient's.
Sec.   482.102...................  (b) introductory text....  Transplant centers......  Transplant programs.
Sec.   482.102...................  (b)(1)...................  transplant center.......  transplant program.
Sec.   482.102...................  (b)(4)...................  beneficiary.............  recipient.
Sec.   482.102...................  (b)(6)...................  transplant center-        transplant program-
                                                               specific.                 specific.
Sec.   482.102...................  (b)(6)...................  beneficiaries...........  receipients.
Sec.   482.102...................  (b)(6)...................  center-specific outcomes  transplant-specific
                                                                                         outcomes.
Sec.   482.102...................  (b)(9)...................  transplant center.......  transplant program.
Sec.   482.102...................  (b)(9)...................  beneficiary's...........  recipient's.
Sec.   482.102...................  (c) introductory text....  Transplant centers......  Transplant programs.
Sec.   482.102...................  (c) introductory text....  center's................  program's.
Sec.   482.102...................  (c) introductory text....  center..................  program.
Sec.   482.102...................  (c)(1) introductory text.  transplant center.......  transplant program.

[[Page 47754]]

 
Sec.   482.102...................  (c)(1) introductory text.  center's waiting list...  program's waiting list.
Sec.   482.102...................  (c)(2)(i)................  center's waiting list...  program's waiting list.
Sec.   482.102...................  (c)(2)(i)................  transplant center.......  transplant program.
Sec.   482.102...................  (c)(2)(ii)...............  beneficiaries...........  recipients.
Sec.   482.102...................  (c)(2)(ii)...............  center's waiting list...  program's waiting list.
Sec.   482.102...................  (c)(2)(ii)...............  the center..............  the program.
Sec.   482.102...................  (c)(2)(ii)...............  center's termination of   program's termination of
                                                               approval.                 approval.
Sec.   482.102...................  (c)(3)...................  transplant center's.....  transplant program's.
Sec.   482.102...................  (c)(3)...................  the center..............  the program.
Sec.   482.102...................  (c)(3)...................  center's waiting list...  program's waiting list.
Sec.   482.102...................  (c)(3)...................  transplant center.......  transplant program.
----------------------------------------------------------------------------------------------------------------

0
32. Section 482.102 is further amended by revising paragraph (a)(5) to 
read as follows:


Sec.  482.102   Condition of participation: Patient and living donor 
rights.

* * * * *
    (a) * * *
    (5) National and transplant program-specific outcomes, from the 
most recent SRTR program-specific report, including (but not limited 
to) the transplant program's observed and expected 1-year patient and 
graft survival, and national 1-year patient and graft survival;
* * * * *


Sec.  482.104  [Amended]

0
33. For Sec.  482.104, in the following table, for the heading and each 
paragraph indicated in the first column, remove the phrase indicated in 
the second column each time it appears and add the reference indicated 
in the third column:

------------------------------------------------------------------------
         Paragraphs                  Remove                  Add
------------------------------------------------------------------------
Section heading.............  transplant centers..  transplant programs.
(a).........................  transplant centers..  transplant programs.
(a).........................  transplant center...  transplant program.
(b).........................  transplant centers..  transplant programs.
(c).........................  transplant centers..  transplant programs.
------------------------------------------------------------------------

PART 483--REQUIREMENTS FOR STATES AND LONG TERM CARE FACILITIES

0
34. The authority citation for part 483 continues to read as follows:

    Authority: Secs. 1102, 1128I, 1819, 1871 and 1919 of the Social 
Security Act (42 U.S.C. 1302, 1320a-7, 1395i, 1395hh and 1396r).

0
35. Section 483.73 is amended by--
0
a. Revising paragraphs (a) introductory text, (a)(4), (b) introductory 
text, (c) introductory text, (d) introductory text, and (d)(1)(ii);
0
b. Adding paragraph (d)(1)(v); and
0
c. Revising paragraph (d)(2).
    The revisions and addition read as follows:


Sec.  483.73  Emergency preparedness.

* * * * *
    (a) Emergency plan. The LTC facility must develop and maintain an 
emergency preparedness plan that must be reviewed, and updated at least 
every 2 years. The plan must do all of the following:
* * * * *
    (4) Include a process for cooperation and collaboration with local, 
tribal, regional, State, or Federal emergency preparedness officials' 
efforts to maintain an integrated response during a disaster or 
emergency situation.
    (b) Policies and procedures. The LTC facility must develop and 
implement emergency preparedness policies and procedures, based on the 
emergency plan set forth in paragraph (a) of this section, risk 
assessment at paragraph (a)(1) of this section, and the communication 
plan at paragraph (c) of this section. The policies and procedures must 
be reviewed and updated at least every 2 years. At a minimum, the 
policies and procedures must address the following:
* * * * *
    (c) Communication plan. The LTC facility must develop and maintain 
an emergency preparedness communication plan that complies with 
Federal, State, and local laws and must be reviewed and updated at 
least every 2 years. The communication plan must include all of the 
following:
* * * * *
    (d) Training and testing. The LTC facility must develop and 
maintain an emergency preparedness training and testing program that is 
based on the emergency plan set forth in paragraph (a) of this section, 
risk assessment at paragraph (a)(1) of this section, policies and 
procedures at paragraph (b) of this section, and the communication plan 
at paragraph (c) of this section. The training and testing program must 
be reviewed and updated at least every 2 years.
    (1) * * *
    (ii) Provide emergency preparedness training at least every 2 
years.
* * * * *
    (v) If the emergency preparedness policies and procedures are 
significantly updated, the LTC facility must conduct training on the 
updated policies and procedures.
    (2) Testing. The LTC facility must conduct exercises to test the 
emergency plan at least twice per year, including unannounced staff 
drills using the emergency procedures. The LTC facility must do the 
following:
    (i) Participate in an annual full-scale exercise that is community-
based or when a community-based exercise is not accessible, an 
individual, facility-based functional exercise annually. If the LTC 
facility experiences an actual natural or man-made emergency that 
requires activation of the emergency plan, the LTC facility is exempt 
from engaging its next required a full-scale community-based or 
individual, facility-based functional exercise following the onset of 
the actual event.
    (ii) Conduct an additional exercise at least annually that may 
include, but is not limited to the following:
    (A) A second full-scale exercise that is community-based or an 
individual, facility-based functional exercise; or
    (B) A mock disaster drill; or
    (C) A tabletop exercise or workshop that includes a group 
discussion led by

[[Page 47755]]

a facilitator, using a narrated, clinically-relevant emergency 
scenario, and a set of problem statements, directed messages, or 
prepared questions designed to challenge an emergency plan.
    (iii) Analyze the LTC facility's response to and maintain 
documentation of all drills, tabletop exercises, and emergency events, 
and revise the LTC facility's emergency plan, as needed.
* * * * *
0
36. Section 483.475 is amended by--
0
a. Revising paragraphs (a) introductory text, (a)(4), (b) introductory 
text, (c) introductory text, (d) introductory text, and (d)(1)(ii);
0
b. Adding paragraph (d)(1)(v); and
0
c. Revising paragraph (d)(2).
    The revisions and addition read as follows:


Sec.  483.475  Condition of participation: Emergency preparedness.

* * * * *
    (a) Emergency plan. The ICF/IID must develop and maintain an 
emergency preparedness plan that must be reviewed, and updated at least 
every 2 years The plan must do all of the following:
* * * * *
    (4) 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.
    (b) Policies and procedures. The ICF/IID must develop and implement 
emergency preparedness policies and procedures, based on the emergency 
plan set forth in paragraph (a) of this section, risk assessment at 
paragraph (a)(1) of this section, and the communication plan at 
paragraph (c) of this section. The policies and procedures must be 
reviewed and updated at least every 2 years. At a minimum, the policies 
and procedures must address the following:
* * * * *
    (c) Communication plan. The ICF/IID must develop and maintain an 
emergency preparedness communication plan that complies with Federal, 
State, and local laws and must be reviewed and updated at least every 2 
years. The communication plan must include the following:
* * * * *
    (d) Training and testing. The ICF/IID must develop and maintain an 
emergency preparedness training and testing program that is based on 
the emergency plan set forth in paragraph (a) of this section, risk 
assessment at paragraph (a)(1) of this section, policies and procedures 
at paragraph (b) of this section, and the communication plan at 
paragraph (c) of this section. The training and testing program must be 
reviewed and updated at least every 2 years. The ICF/IID must meet the 
requirements for evacuation drills and training at Sec.  483.470(i).
    (1) * * *
    (ii) Provide emergency preparedness training at least every 2 
years.
* * * * *
    (v) If the emergency preparedness policies and procedures are 
significantly updated, the ICF/IID must conduct training on the updated 
policies and procedures.
    (2) Testing. The ICF/IID must conduct exercises to test the 
emergency plan at least twice per year. The ICF/IID must do the 
following:
    (i) Participate in an annual full-scale exercise that is community-
based or when a community-based exercise is not accessible, an 
individual, facility-based functional exercise annually. If the ICF/IID 
experiences an actual natural or man-made emergency that requires 
activation of the emergency plan, the ICF/IID is exempt from engaging 
in its next required full-scale community-based or individual, 
facility-based functional exercise following the onset of the actual 
event.
    (ii) Conduct an additional exercise at least annually that may 
include, but is not limited to the following:
    (A) A second full-scale exercise that is community-based or an 
individual, facility-based functional exercise; or
    (B) A mock disaster drill; or
    (C) A tabletop exercise or workshop that includes a group 
discussion led by a facilitator, using a narrated, clinically-relevant 
emergency scenario, and a set of problem statements, directed messages, 
or prepared questions designed to challenge an emergency plan.
    (iii) Analyze the ICF/IID's response to and maintain documentation 
of all drills, tabletop exercises, and emergency events, and revise the 
ICF/IID's emergency plan, as needed.
* * * * *

PART 484--HOME HEALTH SERVICES

0
37. The authority citation for part 484 continues to read as follows:

    Authority: Secs. 1102 and 1871 of the Social Security Act (42 
U.S.C. 1302 and 1395(hh)) unless otherwise indicated.

0
38. Section 484.50 is amended by removing and reserving paragraph 
(a)(3) and revising paragraph (c)(7) introductory text to read as 
follows:


Sec.  484.50   Condition of participation: Patient rights.

* * * * *
    (c) * * *
    (7) Be advised, orally and in writing, of--
* * * * *
0
39. Section 484.80 is amended by revising paragraph (h)(3) to read as 
follows:


Sec.  484.80  Condition of participation: Home health aide services.

* * * * *
    (h) * * *
    (3) If a deficiency in aide services is verified by the registered 
nurse or other appropriate skilled professional during an on-site 
visit, then the agency must conduct, and the home health aide must 
complete, retraining and a competency evaluation related to the 
deficient skill(s).
* * * * *
0
40. Section 484.102 is amended by--
0
a. Revising paragraphs (a) introductory text, (a)(4), (b) introductory 
text, (c) introductory text, and (d) introductory text and the first 
paragraph (d)(1)(ii);
0
b. Redesignating the second paragraph (d)(1)(ii) as paragraph 
(d)(1)(iv);
0
c. Adding paragraph (d)(1)(v); and
0
d. Revising paragraph (d)(2).
    The revisions and addition read as follows:


Sec.  484.102  Condition of participation: Emergency preparedness.

* * * * *
    (a) Emergency plan. The HHA must develop and maintain an emergency 
preparedness plan that must be reviewed, and updated at least every 2 
years. The plan must do all of the following:
* * * * *
    (4) 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.
    (b) Policies and procedures. The HHA must develop and implement 
emergency preparedness policies and procedures, based on the emergency 
plan set forth in paragraph (a) of this section, risk assessment at 
paragraph (a)(1) of this section, and the communication plan at 
paragraph (c) of this section. The policies and procedures must be 
reviewed and updated at least every 2 years. At a minimum, the policies 
and procedures must address the following:
* * * * *
    (c) Communication plan. The HHA must develop and maintain an

[[Page 47756]]

emergency preparedness communication plan that complies with Federal, 
State, and local laws and must be reviewed and updated at least every 2 
years. The communication plan must include all of the following:
* * * * *
    (d) Training and testing. The HHA must develop and maintain an 
emergency preparedness training and testing program that is based on 
the emergency plan set forth in paragraph (a) of this section, risk 
assessment at paragraph (a)(1) of this section, policies and procedures 
at paragraph (b) of this section, and the communication plan at 
paragraph (c) of this section. The training and testing program must be 
reviewed and updated at least every 2 years.
    (1) * * *
    (ii) Provide emergency preparedness training at least every 2 
years.
* * * * *
    (v) If the emergency preparedness policies and procedures are 
significantly updated, the HHA must conduct training on the updated 
policies and procedures.
    (2) Testing. The HHA must conduct exercises to test the emergency 
plan at least annually. The HHA must do the following:
    (i) Participate in a full-scale exercise that is community-based or 
when a community-based exercise is not accessible, an individual, 
facility-based functional exercise every 2 years. If the HHA 
experiences an actual natural or man-made emergency that requires 
activation of the emergency plan, the HHA is exempt from engaging in 
its next required full-scale community-based or individual, facility-
based functional exercise following the onset of the actual event.
    (ii) Conduct an additional exercise at least every 2 years, 
opposite the year the full-scale or functional exercise under paragraph 
(d)(2)(i) of this section is conducted, that may include, but is not 
limited to the following:
    (A) A second full-scale exercise that is community-based or an 
individual, facility-based functional exercise; or
    (B) A mock disaster drill; or
    (C) A tabletop exercise or workshop that includes a group 
discussion led by a facilitator, using a narrated, clinically-relevant 
emergency scenario, and a set of problem statements, directed messages, 
or prepared questions designed to challenge an emergency plan.
    (iii) Analyze the HHA's response to and maintain documentation of 
all drills, tabletop exercises, and emergency events, and revise the 
HHA's emergency plan, as needed.
* * * * *
0
41. Section 484.110 is amended by revising paragraph (e) to read as 
follows:


Sec.  484.110  Condition of participation: Clinical records.

* * * * *
    (e) Standard: Retrieval of clinical records. A patient's clinical 
record (whether hardcopy or electronic form) must be made available to 
a patient, free of charge, upon request within 4 business days.

PART 485--CONDITIONS OF PARTICIPATION: SPECIALIZED PROVIDERS

0
42. The authority citation for part 485 continues to read as follows:

    Authority: Secs. 1102 and 1871 of the Social Security Act (42 
U.S.C. 1302 and 1395(hh)).

0
43. Section 485.66 is amended by revising the introductory text to read 
as follows:


Sec.  485.66  Condition of participation: Utilization review plan.

    The facility must have in effect a written utilization review plan 
that is implemented annually, to assess the necessity of services and 
promotes the most efficient use of services provided by the facility.
* * * * *
0
44. Section 485.68 is amended by--
0
a. Revising paragraphs (a) introductory text, (a)(4), (b) introductory 
text, (c) introductory text, (d) introductory text, and (d)(1)(ii);
0
b. Adding paragraph (d)(1)(v); and
0
c. Revising paragraph (d)(2).
    The revisions and addition read as follows:


Sec.  485.68  Condition of participation: Emergency preparedness.

* * * * *
    (a) Emergency plan. The CORF must develop and maintain an emergency 
preparedness plan that must be reviewed and updated at least every 2 
years. The plan must do all of the following:
* * * * *
    (4) 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.
* * * * *
    (b) Policies and procedures. The CORF must develop and implement 
emergency preparedness policies and procedures, based on the emergency 
plan set forth in paragraph (a) of this section, risk assessment at 
paragraph (a)(1) of this section, and the communication plan at 
paragraph (c) of this section. The policies and procedures must be 
reviewed and updated at least every 2 years. At a minimum, the policies 
and procedures must address the following:
* * * * *
    (c) Communication plan. The CORF must develop and maintain an 
emergency preparedness communication plan that complies with Federal, 
State, and local laws and must be reviewed and updated at least every 2 
years. The communication plan must include all of the following:
* * * * *
    (d) Training and testing. The CORF must develop and maintain an 
emergency preparedness training and testing program that is based on 
the emergency plan set forth in paragraph (a) of this section, risk 
assessment at paragraph (a)(1) of this section, policies and procedures 
at paragraph (b) of this section, and the communication plan at 
paragraph (c) of this section. The training and testing program must be 
reviewed and updated at least every 2 years.
    (1) * * *
    (ii) Provide emergency preparedness training at least every 2 
years.
* * * * *
    (v) If the emergency preparedness policies and procedures are 
significantly updated, the CORF must conduct training on the updated 
policies and procedures.
    (2) Testing. The CORF must conduct exercises to test the emergency 
plan at least annually. The CORF must do the following:
    (i) Participate in a full-scale exercise that is community-based or 
when a community-based exercise is not accessible, an individual, 
facility-based functional exercise every 2 years. If the CORF 
experiences an actual natural or man-made emergency that requires 
activation of the emergency plan, the CORF is exempt from engaging in 
its next required community-based or individual, facility-based 
functional exercise following the onset of the actual event.
    (ii) Conduct an additional exercise at least every 2 years, 
opposite the year the full-scale or functional exercise under paragraph 
(d)(2)(i) of this section is conducted, that may include, but is not 
limited to the following:
    (A) A second full-scale exercise that is community-based or an 
individual, facility-based functional exercise; or
    (B) A mock disaster drill; or

[[Page 47757]]

    (C) A tabletop exercise or workshop that includes a group 
discussion led by a facilitator, using a narrated, clinically-relevant 
emergency scenario, and a set of problem statements, directed messages, 
or prepared questions designed to challenge an emergency plan.
    (iii) Analyze the CORF's response to and maintain documentation of 
all drills, tabletop exercises, and emergency events, and revise the 
CORF's emergency plan, as needed.
* * * * *
0
45. Section 485.625 is amended by--
0
a. Revising paragraphs (a) introductory text, (a)(4), (b) introductory 
text, (c) introductory text, (d) introductory text, and (d)(1)(ii);
0
b. Adding paragraph (d)(1)(v); and
0
c. Revising paragraph (d)(2).
    The revisions and addition read as follows:


Sec.  485.625  Condition of participation: Emergency preparedness.

* * * * *
    (a) Emergency plan. The CAH must develop and maintain an emergency 
preparedness plan that must be reviewed and updated at least every 2 
years. The plan must do all of the following:
* * * * *
    (4) 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.
    (b) Policies and procedures. The CAH must develop and implement 
emergency preparedness policies and procedures, based on the emergency 
plan set forth in paragraph (a) of this section, risk assessment at 
paragraph (a)(1) of this section, and the communication plan at 
paragraph (c) of this section. The policies and procedures must be 
reviewed and updated at least every 2 years. At a minimum, the policies 
and procedures must address the following:
* * * * *
    (c) Communication plan. The CAH must develop and maintain an 
emergency preparedness communication plan that complies with Federal, 
State, and local laws and must be reviewed and updated at least every 2 
years. The communication plan must include all of the following:
* * * * *
    (d) Training and testing. The CAH must develop and maintain an 
emergency preparedness training and testing program that is based on 
the emergency plan set forth in paragraph (a) of this section, risk 
assessment at paragraph (a)(1) of this section, policies and procedures 
at paragraph (b) of this section, and the communication plan at 
paragraph (c) of this section. The training and testing program must be 
reviewed and updated at least every 2 years.
    (1) * * *
    (ii) Provide emergency preparedness training at least every 2 
years.
* * * * *
    (v) If the emergency preparedness policies and procedures are 
significantly updated, the CAH must conduct training on the updated 
policies and procedures.
    (2) Testing. The CAH must conduct exercises to test the emergency 
plan at least twice per year. The CAH must do the following:
    (i) Participate in a full-scale exercise that is community-based or 
when a community-based exercise is not accessible, an individual, 
facility-based functional exercise once per year. If the CAH 
experiences an actual natural or man-made emergency that requires 
activation of the emergency plan, the CAH is exempt from engaging in 
its next required full-scale community-based or individual, facility-
based functional exercise following the onset of the actual event.
    (ii) Conduct an additional exercise at least annually, that may 
include, but is not limited to the following:
    (A) A second full-scale exercise that is community-based or an 
individual, facility-based functional exercise; or
    (B) A mock disaster drill; or
    (C) A tabletop exercise or workshop that includes a group 
discussion led by a facilitator, using a narrated, clinically-relevant 
emergency scenario, and a set of problem statements, directed messages, 
or prepared questions designed to challenge an emergency plan.
    (iii) Analyze the CAH's response to and maintain documentation of 
all drills, tabletop exercises, and emergency events, and revise the 
CAH's emergency plan, as needed.
* * * * *


Sec.  485.627  [Amended]

0
46. Section 485.627 is amended by removing and reserving paragraph 
(b)(1).
0
47. Section 485.635 is amended by revising paragraph (a)(4) to read as 
follows:


Sec.  485.635  Condition of participation: Provision of services.

    (a) * * *
    (4) These policies are reviewed at least biennially by the group of 
professional personnel required under paragraph (a)(2) of this section 
and updated as necessary by the CAH.
* * * * *
0
48. Section 485.645 is amended by--
0
a. Revising paragraph (d)(1);
0
b. Removing paragraph (d)(4);
0
c. Redesignating paragraphs (d)(5) through (9) as paragraphs (d)(4) 
through (8), respectively; and
0
d. Revising newly redesignated paragraphs (d)(4) and (7).
    The revisions read as follows:


Sec.  485.645  Special requirements for CAH providers of long-term care 
services (``swing-beds'').

* * * * *
    (d) * * *
    (1) Resident rights (Sec.  483.10(b)(7), (c)(1), (c)(2)(iii), 
(c)(6), (d), (e)(2) and (4), (f)(4)(ii) and (iii), (g)(8) and (17), 
(g)(18) introductory text, and (h) of this chapter).
* * * * *
    (4) Social services (Sec.  483.40(d) of this chapter).
* * * * *
    (7) Dental services (Sec.  483.55(a)(2), (3), (4), and (5) and (b) 
of this chapter).
* * * * *
0
49. Section 485.727 is amended by--
0
a. Revising paragraphs (a) introductory text, (a)(5), (b) introductory 
text, (c) introductory text, (d) introductory text, and (d)(1)(ii);
0
b. Adding paragraph (d)(1)(v); and
0
c. Revising paragraph (d)(2).
    The revisions and addition read as follows:


Sec.  485.727   Condition of participation: Emergency preparedness.

* * * * *
    (a) Emergency plan. The Organizations must develop and maintain an 
emergency preparedness plan that must be reviewed and updated at least 
every 2 years. The plan must do all of the following:
* * * * *
    (5) 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.
* * * * *
    (b) Policies and procedures. The Organizations must develop and 
implement emergency preparedness policies and procedures, based on the 
emergency plan set forth in paragraph (a) of this section, risk 
assessment at paragraph (a)(1) of this section, and the communication 
plan at paragraph (c) of this section. The policies and procedures must 
be reviewed and

[[Page 47758]]

updated at least every 2 years. At a minimum, the policies and 
procedures must address the following:
* * * * *
    (c) Communication plan. The Organizations must develop and maintain 
an emergency preparedness communication plan that complies with 
Federal, State, and local laws and must be reviewed and updated at 
least every 2 years. The communication plan must include all of the 
following:
* * * * *
    (d) Training and testing. The Organizations must develop and 
maintain an emergency preparedness training and testing program that is 
based on the emergency plan set forth in paragraph (a) of this section, 
risk assessment at paragraph (a)(1) of this section, policies and 
procedures at paragraph (b) of this section, and the communication plan 
at paragraph (c) of this section. The training and testing program must 
be reviewed and updated at least every 2 years.
    (1) * * *
    (ii) Provide emergency preparedness training at least every 2 
years.
* * * * *
    (v) If the emergency preparedness policies and procedures are 
significantly updated, the Organizations must conduct training on the 
updated policies and procedures.
    (2) Testing. The Organizations must conduct exercises to test the 
emergency plan at least annually. The Organizations must do the 
following:
    (i) Participate in a full-scale exercise that is community-based or 
when a community-based exercise is not accessible, an individual, 
facility-based functional exercise every 2 years. If the Organizations 
experience an actual natural or man-made emergency that requires 
activation of the emergency plan, the organization is exempt from 
engaging in its next required full-scale community-based or individual, 
facility-based functional exercise following the onset of the actual 
event.
    (ii) Conduct an additional exercise at least every 2 years, 
opposite the year the full-scale or functional exercise under paragraph 
(d)(2)(i) of this section is conducted, that may include, but is not 
limited to the following:
    (A) A second full-scale exercise that is community-based or an 
individual, facility-based functional exercise; or
    (B) A mock disaster drill; or
    (C) A tabletop exercise or workshop that includes a group 
discussion led by a facilitator, using a narrated, clinically-relevant 
emergency scenario, and a set of problem statements, directed messages, 
or prepared questions designed to challenge an emergency plan.
    (iii) Analyze the Organization's response to and maintain 
documentation of all drills, tabletop exercises, and emergency events, 
and revise their emergency plan, as needed.
* * * * *
0
50. Section 485.914 is amended by revising paragraphs (d)(1) and (3) to 
read as follows:


Sec.  485.914  Condition of participation: Admission, initial 
evaluation, comprehensive assessment, and discharge or transfer of the 
client.

* * * * *
    (d) * * *
    (1) The CMHC must update each client's comprehensive assessment via 
the CMHC interdisciplinary treatment team, in consultation with the 
client's primary health care provider (if any), when changes in the 
client's status, responses to treatment, or goal achievement have 
occurred and in accordance with current standards of practice.
* * * * *
    (3) For clients that receive PHP services, the assessment must be 
updated no less frequently than every 30 days.
* * * * *
0
51. Section 485.920 is amended by revising paragraphs (a) introductory 
text, (a)(4), (b) introductory text, (c) introductory text, and (d) to 
read as follows:


Sec.  485.920  Condition of participation: Emergency preparedness.

* * * * *
    (a) Emergency plan. The CMHC must develop and maintain an emergency 
preparedness plan that must be reviewed, and updated at least every 2 
years. The plan must do all of the following:
* * * * *
    (4) 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.
    (b) Policies and procedures. The CMHC must develop and implement 
emergency preparedness policies and procedures, based on the emergency 
plan set forth in paragraph (a) of this section, risk assessment at 
paragraph (a)(1) of this section, and the communication plan at 
paragraph (c) of this section. The policies and procedures must be 
reviewed and updated at least every 2 years. At a minimum, the policies 
and procedures must address the following:
* * * * *
    (c) Communication plan. The CMHC must develop and maintain an 
emergency preparedness communication plan that complies with Federal, 
State, and local laws and must be reviewed and updated at least every 2 
years. The communication plan must include all of the following:
* * * * *
    (d) Training and testing. The CMHC must develop and maintain an 
emergency preparedness training and testing program that is based on 
the emergency plan set forth in paragraph (a) of this section, risk 
assessment at paragraph (a)(1) of this section, policies and procedures 
at paragraph (b) of this section, and the communication plan at 
paragraph (c) of this section. The training and testing program must be 
reviewed and updated at least every 2 years. If the emergency 
preparedness policies and procedures are significantly updated, the 
CMHC must conduct training on the updated policies and procedures.
    (1) Training. The CMHC must provide initial training in emergency 
preparedness policies and procedures to all new and existing staff, 
individuals providing services under arrangement, and volunteers, 
consistent with their expected roles, and maintain documentation of the 
training. The CMHC must demonstrate staff knowledge of emergency 
procedures. Thereafter, the CMHC must provide emergency preparedness 
training at least every 2 years.
    (2) Testing. The CMHC must conduct exercises to test the emergency 
plan at least annually. The CMHC must:
    (i) Participate in a full-scale exercise that is community-based or 
when a community-based exercise is not accessible, an individual, 
facility-based every 2 years. If the CMHC experiences an actual natural 
or man-made emergency that requires activation of the emergency plan, 
the CMHC is exempt from engaging in its next required community-based 
or individual, facility-based functional exercise following the onset 
of the actual event.
    (ii) Conduct an additional exercise at least every 2 years, 
opposite the year the full-scale or functional exercise under paragraph 
(d)(2)(i) of this section is conducted, that may include, but is not 
limited to following:
    (A) A second full-scale exercise that is community-based or an 
individual, facility-based functional exercise; or
    (B) A mock disaster drill; or

[[Page 47759]]

    (C) A tabletop exercise or workshop that includes a group 
discussion led by a facilitator, using a narrated, clinically-relevant 
emergency scenario, and a set of problem statements, directed messages, 
or prepared questions designed to challenge an emergency plan.
    (iii) Analyze the CMHC's response to and maintain documentation of 
all drills, tabletop exercises, and emergency events, and revise the 
CMHC's emergency plan, as needed.
* * * * *

PART 486--CONDITIONS FOR COVERAGE OF SPECIALIZED SERVICES FURNISHED 
BY SUPPLIERS

0
52. The authority citation for part 486 continues to read as follows:

    Authority: Secs. 1102, 1138, and 1871 of the Social Security Act 
(42 U.S.C. 1302, 1320b-8, and 1395hh) and section 371 of the Public 
Health Service Act (42 U.S.C 273).

0
53. Section 486.104 is amended by revising paragraph (a) to read as 
follows:


Sec.  486.104  Condition for coverage: Qualifications, orientation and 
health of technical personnel.

* * * * *
    (a) Standard: qualifications of technologists. All operators of the 
portable X-ray equipment meet the requirements of paragraph (a)(1) or 
(2) of this section.
    (1) Successful completion of a program of formal training in X-ray 
technology at which the operator received appropriate training and 
demonstrated competence in the use of equipment and administration of 
portable x-ray procedures; or
    (2) Successful completion of 24 full months of training and 
experience under the direct supervision of a physician who is certified 
in radiology or who possesses qualifications which are equivalent to 
those required for such certification.
* * * * *
0
54. Section 486.106 is amended by revising paragraph (a)(2) to read as 
follows:


Sec.  486.106  Conditions for coverage: Referral for service and 
preservation of records.

* * * * *
    (a) * * *
    (2) Such physician or nonphysician practitioner's order meets the 
requirements at Sec.  410.32 of this chapter, and includes a statement 
concerning the condition of the patient which indicates why portable X-
ray services are necessary.
* * * * *
0
55. Section 486.360 is amended by--
0
a. Revising paragraphs (a) introductory text, (a)(4), (b) introductory 
text, (c) introductory text, (d) introductory text, and (d)(1)(ii);
0
b. Adding paragraph (d)(1)(v); and
0
c. Revising paragraph (d)(2)(i).
    The revisions and addition read as follows:


Sec.  486.360  Condition for coverage: Emergency preparedness.

* * * * *
    (a) Emergency plan. The OPO must develop and maintain an emergency 
preparedness plan that must be reviewed and updated at least every 2 
years. The plan must do all of the following:
* * * * *
    (4) 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.
    (b) Policies and procedures. The OPO must develop and implement 
emergency preparedness policies and procedures, based on the emergency 
plan set forth in paragraph (a) of this section, risk assessment at 
paragraph (a)(1) of this section, and, the communication plan at 
paragraph (c) of this section. The policies and procedures must be 
reviewed and updated at least every 2 years. At a minimum, the policies 
and procedures must address the following:
* * * * *
    (c) Communication plan. The OPO must develop and maintain an 
emergency preparedness communication plan that complies with Federal, 
State, and local laws and must be reviewed and updated at least every 2 
years. The communication plan must include all of the following:
* * * * *
    (d) Training and testing. The OPO must develop and maintain an 
emergency preparedness training and testing program that is based on 
the emergency plan set forth in paragraph (a) of this section, risk 
assessment at paragraph (a)(1) of this section, policies and procedures 
at paragraph (b) of this section, and the communication plan at 
paragraph (c) of this section. The training and testing program must be 
reviewed and updated at least every 2 years.
    (1) * * *
    (ii) Provide emergency preparedness training at every 2 years.
* * * * *
    (v) If the emergency preparedness policies and procedures are 
significantly updated, the OPO must conduct training on the updated 
policies and procedures.
    (2) * * *
    (i) Conduct a paper-based, tabletop exercise or workshop at least 
annually. A tabletop exercise is a group discussion led by a 
facilitator, using a narrated, clinically-relevant emergency scenario, 
and a set of problem statements, directed messages, or prepared 
questions designed to challenge an emergency plan. If the OPO 
experiences an actual natural or man-made emergency that requires 
activation of the emergency plan, the OPO is exempt from engaging in 
its next required testing exercise following the onset of the actual 
event.
* * * * *

PART 488--SURVEY, CERTIFICATION, AND ENFORCEMENT PROCEDURES

0
56. The authority citation for part 488 continues to read as follows:

    Authority: Secs. 1102, 1128l, 1864, 1865, 1871 and 1875 of the 
Social Security Act, unless otherwise noted (42 U.S.C 1302, 1320a-
7j, 1395aa, 1395bb, 1395hh and 1395ll).


Sec.  488.30  [Amended]

0
57. Section 488.30(a) is amended in the definition for ``Provider of 
services, provider, or supplier'' by removing the phrase ``transplant 
centers'' and adding in its place the phrase ``transplant programs''.
0
58. Section 488.61 is amended--
0
a. By revising the section heading;
0
b. In the introductory text by removing the phrase ``transplant 
centers'' and adding in its place the phrase ``transplant programs'';
0
c. In paragraph (a) by removing the phrases ``centers'' and ``center'' 
each time they appear and adding in their place the phrases 
``programs'' and ``program,'' respectively;
0
d. In paragraph (a)(2) by removing the phrases ``Scientific Registry of 
Transplant Beneficiary (SRTR) center-specific'' and ``Scientific 
Registry of Transplant Recipient (SRTR) program-specific'' and adding 
in its place the phrase ``Scientific Registry of Transplant Recipient 
(SRTR) program-specific'';
0
e. By revising paragraph (a)(5);
0
f. By removing paragraph (c);
0
g. By redesignating paragraphs (d) through (h) as paragraphs (c) 
through (g), respectively;
0
h. By revising newly redesignated paragraphs (c), (d), (e) introductory 
text, (e)(1) introductory text, (e)(1)(iv), (e)(3), and (f)(1)(i), 
(ii), and (iii).
    The revisions read as follows:

[[Page 47760]]

Sec.  488.61  Special procedures for approval and re-approval of organ 
transplant programs.

* * * * *
    (a) * * *
    (5) If CMS determines that a transplant program has met the data 
submission, clinical experience, and outcome requirements, CMS will 
review the program's compliance with the conditions of participation 
contained at Sec. Sec.  482.72 through 482.76 and Sec. Sec.  482.90 
through 482.104 of this chapter using the procedures described in 
subpart A of this part. If the transplant program is found to be in 
compliance with all the conditions of participation at Sec. Sec.  
482.72 through 482.104 of this chapter, CMS will notify the transplant 
program in writing of the effective date of its Medicare-approval. CMS 
will notify the transplant program in writing if it is not Medicare-
approved.
* * * * *
    (c) Loss of Medicare approval. Programs that have lost their 
Medicare approval may seek re-entry into the Medicare program at any 
time. A program that has lost its Medicare approval must:
    (1) Request initial approval using the procedures described in 
paragraph (a) of this section;
    (2) Be in compliance with Sec. Sec.  482.72 through 482.104 of this 
chapter at the time of the request for Medicare approval; and
    (3) Submit a report to CMS documenting any changes or corrective 
actions taken by the program as a result of the loss of its Medicare 
approval status.
    (d) Transplant program inactivity. A transplant program may remain 
inactive and retain its Medicare approval for a period not to exceed 12 
months. A transplant program must notify CMS upon its voluntary 
inactivation as required by Sec.  482.74(a)(3) of this chapter.
    (e) Consideration of mitigating factors in initial approval survey, 
certification, and enforcement actions for transplant programs--(1) 
Factors. Except for situations of immediate jeopardy or deficiencies 
other than failure to meet requirements at Sec.  482.80 of this 
chapter, CMS will consider such mitigating factors as may be 
appropriate in light of the nature of the deficiency and circumstances, 
including (but not limited to) the following, in making a decision of 
initial approval of a transplant program that does not meet the data 
submission, clinical experience, or outcome requirements:
* * * * *
    (iv) Program improvements that substantially address root causes of 
graft failures or patient deaths, that have been implemented and 
institutionalized on a sustainable basis, and that are supported by 
outcomes more recent than the latest available SRTR report, for which 
there is a sufficient post-transplant patient and graft survival period 
and a sufficient number of transplants such that CMS finds that the 
program demonstrates present-day compliance with the requirements at 
Sec.  482.80(c)(2)(ii)(C) of this chapter;
* * * * *
    (3) Timing. Within 14 calendar days after CMS has issued formal 
written notice of a condition-level deficiency to the program, CMS must 
receive notification of the program's intent to seek mitigating factors 
approval, and receive all information for consideration of mitigating 
factors within 120 calendar days of the CMS written notification for a 
deficiency due to data submission, clinical experience or outcomes at 
Sec.  482.80 of this chapter. Failure to meet these timeframes may be 
the basis for denial of mitigating factors. CMS may permit an extension 
of the timeline for good cause, such as a declared public health 
emergency.
    (f) * * *
    (1) * * *
    (i) Approve initial approval of a program's Medicare participation 
based upon approval of mitigating factors.
    (ii) Deny the program's request for Medicare approval based on 
mitigating factors.
    (iii) Offer a time-limited Systems Improvement Agreement, in 
accordance with paragraph (g) of this section, when a transplant 
program has waived its appeal rights, has implemented substantial 
program improvements that address root causes and are institutionally 
supported by the hospital's governing body on a sustainable basis, and 
has requested more time to design or implement additional improvements 
or demonstrate compliance with CMS outcome requirements. Upon 
completion of the Systems Improvement Agreement or a CMS finding that 
the hospital has failed to meet the terms of the Agreement, CMS makes a 
final determination of whether to approve or deny a program's request 
for Medicare approval based on mitigating factors. A Systems 
Improvement Agreement follows the process specified in paragraph (g) of 
this section.
* * * * *

PART 491--CERTIFICATION OF CERTAIN HEALTH FACILITIES

0
59. The authority citation for part 491 continues to read as follows:

    Authority: Sec. 1102 of the Social Security Act (42 U.S.C. 
1302); and sec. 353 of the Public Health Service Act (42 U.S.C. 
263a).

0
60. Section 491.9 is amended by revising paragraph (b)(4) to read as 
follows:


Sec.  491.9  Provision of services.

* * * * *
    (b) * * *
    (4) These policies are reviewed at least biennially by the group of 
professional personnel required under paragraph (b)(2) of this section 
and reviewed as necessary by the RHC or FQHC.
* * * * *
0
61. Section 491.11 is amended by revising paragraph (a) to read as 
follows:


Sec.  491.11  Program evaluation.

    (a) The clinic or center carries out, or arranges for, a biennial 
evaluation of its total program.
* * * * *
0
62. Section 491.12 is amended by--
0
a. Revising paragraphs (a) introductory text, (a)(4), (b) introductory 
text, (c) introductory text, (d) introductory text, and (d)(1)(ii);
0
b. Adding paragraph (d)(1)(v); and
0
c. Revising paragraph (d)(2).
    The revisions and addition read as follows:


Sec.  491.12  Emergency preparedness.

* * * * *
    (a) Emergency plan. The RHC or FQHC must develop and maintain an 
emergency preparedness plan that must be reviewed and updated at least 
every 2 years. The plan must do all of the following:
* * * * *
    (4) 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.
    (b) Policies and procedures. The RHC or FQHC must develop and 
implement emergency preparedness policies and procedures, based on the 
emergency plan set forth in paragraph (a) of this section, risk 
assessment at paragraph (a)(1) of this section, and the communication 
plan at paragraph (c) of this section. The policies and procedures must 
be reviewed and updated at least every 2 years. At a minimum, the 
policies and procedures must address the following:
* * * * *
    (c) Communication plan. The RHC or FQHC must develop and maintain 
an emergency preparedness communication plan that complies with

[[Page 47761]]

Federal, State, and local laws and must be reviewed and updated at 
least every 2 years. The communication plan must include all of the 
following:
* * * * *
    (d) Training and testing. The RHC or FQHC must develop and maintain 
an emergency preparedness training and testing program that is based on 
the emergency plan set forth in paragraph (a) of this section, risk 
assessment at paragraph (a)(1) of this section, policies and procedures 
at paragraph (b) of this section, and the communication plan at 
paragraph (c) of this section. The training and testing program must be 
reviewed and updated at least every 2 years.
    (1) * * *
    (ii) Provide emergency preparedness training at least every 2 
years.
* * * * *
    (v) If the emergency preparedness policies and procedures are 
significantly updated, the RHC/FQHC must conduct training on the 
updated policies and procedures.
    (2) Testing. The RHC or FQHC must conduct exercises to test the 
emergency plan at least annually. The RHC or FQHC must do the 
following:
    (i) Participate in a full-scale exercise that is community-based or 
when a community-based exercise is not accessible, an individual, 
facility-based functional exercise every 2 years. If the RHC or FQHC 
experiences an actual natural or man-made emergency that requires 
activation of the emergency plan, the RHC or FQHC is exempt from 
engaging in its next required full-scale community-based or individual, 
facility-based functional exercise following the onset of the actual 
event.
    (ii) Conduct an additional exercise at least every 2 years, 
opposite the year the full-scale or functional exercise under paragraph 
(d)(2)(i) of this section is conducted, that may include, but is not 
limited to following:
    (A) A second full-scale exercise that is community-based or an 
individual, facility-based functional exercise; or
    (B) A mock disaster drill; or
    (C) A tabletop exercise or workshop that includes a group 
discussion led by a facilitator, using a narrated, clinically-relevant 
emergency scenario, and a set of problem statements, directed messages, 
or prepared questions designed to challenge an emergency plan.
    (iii) Analyze the RHC or FQHC's response to and maintain 
documentation of all drills, tabletop exercises, and emergency events, 
and revise the RHC or FQHC's emergency plan, as needed.
* * * * *

PART 494--CONDITIONS FOR COVERAGE FOR END-STAGE RENAL DISEASE 
FACILITIES

0
63. The authority citation for part 494 continues to read as follows:

    Authority: Secs. 1102 and 1871 of the Social Security Act (42 
U.S.C. l302 and l395hh).

0
64. Section 494.62 is amended by--
0
a. Revising paragraphs (a) introductory text, (a)(4), (b) introductory 
text, (c) introductory text, (d) introductory text, and (d)(1)(ii);
0
b. Adding paragraph (d)(1)(vii); and
0
c. Revising paragraph (d)(2).
    The revisions and addition read as follows:


Sec.  494.62  Condition of participation: Emergency preparedness.

* * * * *
    (a) Emergency plan. The dialysis facility must develop and maintain 
an emergency preparedness plan that must be evaluated and updated at 
least every 2 years. The plan must do all of the following:
* * * * *
    (4) 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. The dialysis facility must contact the local 
emergency preparedness agency at least annually to confirm that the 
agency is aware of the dialysis facility's needs in the event of an 
emergency.
    (b) Policies and procedures. The dialysis facility must develop and 
implement emergency preparedness policies and procedures, based on the 
emergency plan set forth in paragraph (a) of this section, risk 
assessment at paragraph (a)(1) of this section, and the communication 
plan at paragraph (c) of this section. The policies and procedures must 
be reviewed and updated at least every 2 years. These emergencies 
include, but are not limited to, fire, equipment or power failures, 
care-related emergencies, water supply interruption, and natural 
disasters likely to occur in the facility's geographic area. At a 
minimum, the policies and procedures must address the following:
* * * * *
    (c) Communication plan. The dialysis facility must develop and 
maintain an emergency preparedness communication plan that complies 
with Federal, State, and local laws and must be reviewed and updated at 
least every 2 years. The communication plan must include all of the 
following:
* * * * *
    (d) Training, testing, and orientation. The dialysis facility must 
develop and maintain an emergency preparedness training, testing and 
patient orientation program that is based on the emergency plan set 
forth in paragraph (a) of this section, risk assessment at paragraph 
(a)(1) of this section, policies and procedures at paragraph (b) of 
this section, and the communication plan at paragraph (c) of this 
section. The training, testing, and patient orientation program must be 
evaluated and updated at least every 2 years.
    (1) * * *
    (ii) Provide emergency preparedness training at least every 2 
years.
* * * * *
    (vii) If the emergency preparedness policies and procedures are 
significantly updated, the dialysis facility must conduct training on 
the updated policies and procedures.
    (2) Testing. The dialysis facility must conduct exercises to test 
the emergency plan at least annually. The dialysis facility must do all 
of the following:
    (i) Participate in a full-scale exercise that is community-based or 
when a community-based exercise is not accessible, an individual, a 
facility-based functional exercise every 2 years. If the dialysis 
facility experiences an actual natural or man-made emergency that 
requires activation of the emergency plan, the ESRD is exempt from 
engaging in its next required full-scale community-based or individual, 
facility-based functional exercise following the onset of the actual 
event.
    (ii) Conduct an additional exercise at least every 2 years, 
opposite the year the full-scale or functional exercise under paragraph 
(d)(2)(i) of this section is conducted, that may include, but is not 
limited to the following:
    (A) A second full-scale exercise that is community-based or an 
individual, facility-based functional exercise; or
    (B) A mock disaster drill; or
    (C) A tabletop exercise or workshop that includes a group 
discussion led by a facilitator, using a narrated, clinically-relevant 
emergency scenario, and a set of problem statements, directed messages, 
or prepared questions designed to challenge an emergency plan.
    (iii) Analyze the dialysis facility's response to and maintain 
documentation of all drills, tabletop exercises, and emergency events, 
and revise the dialysis facility's emergency plan, as needed.
* * * * *


[[Page 47762]]


    Dated: August 6, 2018.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.
    Dated: August 9, 2018.
Alex M. Azar II,
Secretary, Department of Health and Human Services.
[FR Doc. 2018-19599 Filed 9-17-18; 11:15 am]
 BILLING CODE 4120-01-P