[Federal Register Volume 81, Number 116 (Thursday, June 16, 2016)]
[Proposed Rules]
[Pages 39448-39480]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-13925]



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Vol. 81

Thursday,

No. 116

June 16, 2016

Part IV





Department of Health and Human Services





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Centers for Medicare & Medicaid Services





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42 CFR Parts 482 and 485





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

  Federal Register / Vol. 81 , No. 116 / Thursday, June 16, 2016 / 
Proposed Rules  

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Parts 482 and 485

[CMS-3295-P]
RIN 0938-AS21


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

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

ACTION: Proposed rule.

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SUMMARY: This proposed rule would update the requirements that 
hospitals and critical access hospitals (CAHs) must meet to participate 
in the Medicare and Medicaid programs. These proposals are intended to 
conform the requirements to current standards of practice and support 
improvements in quality of care, reduce barriers to care, and reduce 
some issues that may exacerbate workforce shortage concerns.

DATES: To be assured consideration, comments must be received at one of 
the addresses provided below, no later than 5 p.m. on August 15, 2016.

ADDRESSES: In commenting, please refer to file code CMS-3295-P. Because 
of staff and resource limitations, we cannot accept comments by 
facsimile (FAX) transmission.
    You may submit comments in one of four 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-3295-P, P.O. Box 8010, 
Baltimore, MD 21244.
    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-3295-P, Mail 
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
    4. By hand or courier. Alternatively, you may deliver (by hand or 
courier) your written comments ONLY to the following addresses prior to 
the close of the comment period:
    a. For delivery in Washington, DC--Centers for Medicare & Medicaid 
Services, Department of Health and Human Services, Room 445-G, Hubert 
H. Humphrey Building, 200 Independence Avenue SW., Washington, DC 
20201.
    (Because access to the interior of the Hubert H. Humphrey Building 
is not readily available to persons without Federal government 
identification, commenters are encouraged to leave their comments in 
the CMS drop slots located in the main lobby of the building. A stamp-
in clock is available for persons wishing to retain a proof of filing 
by stamping in and retaining an extra copy of the comments being 
filed.)
    b. For delivery in Baltimore, MD--Centers for Medicare & Medicaid 
Services, Department of Health and Human Services, 7500 Security 
Boulevard, Baltimore, MD 21244-1850.
    If you intend to deliver your comments to the Baltimore address, 
call telephone number (410) 786-9994 in advance to schedule your 
arrival with one of our staff members.
    Comments erroneously mailed to the addresses indicated as 
appropriate for hand or courier delivery may be delayed and received 
after the comment period.
    For information on viewing public comments, see the beginning of 
the SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT: CDR Scott Cooper, USPHS, (410) 786-
9465, Mary Collins, (410) 786-3189, Alpha-Banu Huq, (410) 786-8687, 
Lisa Parker, (410) 786-4665.

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 Web 
site as soon as possible after they have been received: http://www.regulations.gov. Follow the search instructions on that Web site to 
view public comments.
    Comments received timely will also be available for public 
inspection as they are received, generally beginning approximately 3 
weeks after publication of a document, at the headquarters of the 
Centers for Medicare & Medicaid Services, 7500 Security Boulevard, 
Baltimore, Maryland 21244, Monday through Friday of each week from 8:30 
a.m. to 4 p.m. To schedule an appointment to view public comments, 
phone 1-800-743-3951.

Acronyms

    Because of the many terms to which we refer by acronym in this 
proposed rule, we are listing the acronyms used and their corresponding 
meanings in alphabetical order below:

AAPA American Academy of Physician Assistants
ACA Affordable Care Act
AOA American Osteopathic Association
APIC Association for Professionals in Infection Control and 
Epidemiology, Inc.
APRN Advanced Practice Registered Nurse
AS Antibiotic Stewardship
BBA Balanced Budget Act
CAHs Critical Access Hospitals
CARB Combating Antibiotic-Resistant Bacteria
CARE Continuity Assessment Record & Evaluation
CBIC Certification Board of Infection Control and Epidemiology Inc.
CDI Clostridium Difficile Infections
CHA Children's Health Act
CIHQ Center for Improvement in Healthcare Quality
CLABSIs Central Line-Associated Bloodstream Infections
CPOE Computerized Provider Order Entry
CoPs Conditions of Participation
DNV-GL DNV-GL Healthcare
DO Doctor of Osteopathy
DRA Deficit Reduction Act
EM Emergency Medicine
EHRs Electronic Health Records
EWRs Executive WalkRounds
FDA Food and Drug Administration
HACs Hospital-Acquired Conditions
HAIs Healthcare-Associated Infections
HFAP Healthcare Facilities Accreditation Program
HICPAC Healthcare Infection Control Practices Advisory Committee
ICP Infection Control Professional
IDSA Infectious Diseases Society of America
IGs Interpretive Guidelines
IOM Institute of Medicine
IPPS Inpatient Prospective Payment System
IT Information Technology
LGBT Lesbian, Gay, Bisexual, and Transgender
LIP Licensed Independent Practitioner
MBQIP Medicare Beneficiary Quality Improvement Project
MD Doctor of Medicine
MDROs Multi-Drug Resistant Organisms
MedPAC Medicare Payment Advisory Commission
MRHFP Medicare Rural Hospital Flexibility Program
NHSN National Healthcare Safety Network
NQF National Quality Forum
OBRA Omnibus Budget Reconciliation Act
OCR Office for Civil Rights
OIG Office of Inspector General
PA Physician Assistant
PCP Primary Care Provider
PN Parenteral Nutrition
QAPI Quality Assessment and Performance Improvement
QIO Quality Improvement Organization
RDs Registered Dietitians
RPCHs Rural Primary Care Hospitals

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SHEA Society for Healthcare Epidemiology of America
TJC The Joint Commission
VBP Value-Based Purchasing

Table of Contents

    This proposed rule is organized as follows:

I. Background
    A. Executive Summary
    B. Statutory Basis and Purpose of the Conditions of 
Participation for Hospitals and Critical Access Hospitals
    C. Why revise the conditions of participation?
II. Provisions of the Proposed Regulation
    A. Patient's Rights
    1. Non-Discrimination
    2. Licensed Independent Practitioner
    3. Patient's Access to Medical Records
    B. Quality Assessment and Performance Improvement
    C. Nursing Services
    D. Medical Record Services
    E. Infection Prevention and Control and Antibiotic Stewardship 
Programs
    F. Technical Corrections
    G. Critical Access Hospitals
    1. Organizational Structure
    2. Periodic Review of Clinical Privileges and Performance
    3. Provision of Services
    4. Infection Prevention and Control and Antibiotic Stewardship 
Programs
    5. Quality Assessment and Performance Improvement Program
    6. Technical Corrections
III. Collection of Information Requirements
IV. Response to Comments
V. Regulatory Impacts
VI. Regulations Text

I. Background

A. Executive Summary

    These proposed changes would modernize hospital and critical access 
hospital (CAH) requirements, improve quality of care, and support HHS 
and CMS priorities. We believe that benefits of the proposed revisions 
would include; reduced incidence of hospital-acquired conditions 
(HACs), including reduced incidence of healthcare-associated infections 
(HAIs); reduced inappropriate antibiotic use; and strengthened patient 
protections overall. Specifically, we propose to revise the conditions 
of participation (CoPs) for hospitals and CAHs to address:
     Discriminatory behavior by healthcare providers that may 
create real or perceived barriers to care;
     Use of the term ``Licensed Independent Practitioners'' 
(LIPs) that may inadvertently exacerbate workforce shortage concerns;
     Requirements that do not fully conform to current 
standards for infection control;
     Requirements for antibiotic stewardship programs to help 
reduce inappropriate antibiotic use and antimicrobial resistance; and
     The use of quality reporting program data by hospital 
Quality Assessment and Performance Improvement (QAPI) programs.

B. Statutory Basis and Purpose of the Conditions of Participation for 
Hospitals and Critical Access Hospitals

    Sections 1861(e)(1) through (8) of the Social Security Act (the 
Act) provide that a hospital participating in the Medicare program must 
meet certain specified requirements. Section 1861(e)(9) of the Act 
specifies that a hospital also must meet such other requirements as the 
Secretary finds necessary in the interest of the health and safety of 
individuals furnished services in the institution. Under this 
authority, the Secretary has established regulatory requirements that a 
hospital must meet to participate in Medicare at 42 CFR part 482, CoPs 
for Hospitals. Section 1905(a) of the Act provides that Medicaid 
payments from States may be applied to hospital services. Under 
regulations at 42 CFR 440.10(a)(3)(iii) and 42 CFR 440.20(a)(3)(ii), 
hospitals are required to meet the Medicare CoPs in order to 
participate in Medicaid.
    On May 26, 1993, CMS published a final rule in the Federal Register 
entitled ``Medicare Program; Essential Access Community Hospitals 
(EACHs) and Rural Primary Care Hospitals (RPCHs)'' (58 FR 30630) that 
implemented sections 6003(g) and 6116 of the Omnibus Budget 
Reconciliation Act (OBRA) of 1989 and section 4008(d) of OBRA 1990. 
That rule established requirements for the EACH and RPCH providers that 
participated in the seven-state demonstration program that was designed 
to improve access to hospital and other health services for rural 
residents.
    Sections 1820 and 1861(mm) of the Act, as amended by section 4201 
of the Balanced Budget Act (BBA) of 1997, replaced the EACH/RPCH 
program with the Medicare Rural Hospital Flexibility Program (MRHFP), 
under which a qualifying facility can be designated and certified as a 
CAH. CAHs participating in the MRHFP must meet the conditions for 
designation specified in the statute under section 1820(c)(2)(B) of the 
Act, and to be certified must also meet other criteria the Secretary 
may require, under section 1820(e)(3) of the Act. Under this authority, 
the Secretary has established regulatory requirements that a CAH must 
meet to participate in Medicare at 42 CFR part 485, subpart F.
    The CoPs for hospitals and CAHs are organized according to the 
types of services a hospital or CAH may offer, and include specific, 
process oriented requirements for each hospital or CAH service or 
department. The purposes of these conditions are to protect patient 
health and safety and to ensure that quality care is furnished to all 
patients in Medicare-participating hospitals and CAHs. In accordance 
with Section 1864 of the Act, State surveyors assess hospital and CAH 
compliance with the conditions as part of the process of determining 
whether a hospital qualifies for a provider agreement under Medicare. 
However, under section 1865 of the Act, hospitals and CAHs can elect to 
be reviewed instead by private accrediting organizations approved by 
CMS as having standards that meet or exceed the applicable Medicare 
standards and survey procedures comparable to those CMS requires for 
State survey agencies. CMS-approved hospital and CAH accrediting 
programs include those of The Joint Commission (TJC), the American 
Osteopathic Association/Healthcare Facilities Accreditation Program 
(AOA/HFAP), and DNV-GL Healthcare (DNV-GL) (See 42 CFR part 488, Survey 
and Certification Procedures). The Center for Improvement in Healthcare 
Quality (CIHQ) also has a CMS-approved hospital accrediting program.

C. Why revise the conditions of participation?

    CMS is aware, through conversations with stakeholders and federal 
partners, and as a result of internal evaluation and research, of 
continuing concerns about the conditions of participation for hospitals 
and CAHs despite recent revisions to the CoPs. We believe that the 
proposed revisions would address many of those concerns. In addition, 
modernization of the requirements would cumulatively result in improved 
quality of care and improved outcomes for all hospital and CAH 
patients. We believe that benefits would include reduced readmissions, 
reduced incidence of hospital-acquired conditions (including 
healthcare-associated infections), improved use of antibiotics at 
reduced costs (including the potential for reduced antibiotic 
resistance), and improved patient and workforce protections.
    These benefits are consistent with current HHS Quality Initiatives, 
including efforts to prevent HAIs; the national action plan for adverse 
drug event (ADE) prevention; the national strategy for Combating 
Antibiotic-Resistant Bacteria (CARB); and the Department's National 
Quality Strategy (http://www.ahrq.gov/workingforquality/index.html). 
The National Action Plan for Combating

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Antibiotic-Resistant Bacteria, which was developed by the interagency 
Task Force for Combating Antibiotic-Resistant Bacteria in response to 
Executive Order 13676: ``Combating Antibiotic-Resistant Bacteria,'' (79 
FR 56931, Sept. 23, 2014), outlines steps for implementing the National 
Strategy on Combating Antibiotic-Resistant Bacteria and addressing the 
policy recommendations of the President's Council of Advisors on 
Science and Technology report on Combating Antibiotic Resistance. The 
Action Plan includes activities to foster improvements in the 
appropriate use of antibiotics (that is, antibiotic stewardship) by 
improving prescribing practices across all healthcare settings, 
particularly establishment of antimicrobial stewardship programs in all 
acute care hospitals by 2020 (https://www.whitehouse.gov/the-press-office/2015/03/27/fact-sheet-obama-administration-releases-national-action-plan-combat-ant). Our proposal to require hospitals to establish 
and maintain antibiotic stewardship programs would directly support 
this goal. In addition, principles of the National Quality Strategy 
supported by this proposed rule include eliminating disparities in 
care, improving quality, promoting consistent national standards while 
maintaining support for local, community, and State-level activities 
that are responsive to local circumstances; care coordination, and 
providing patients, providers, and payers with the clear information 
they need to make choices that are right for them (http://www.ahrq.gov/workingforquality/nqs/principles.htm). Our proposal to prohibit 
discrimination would support eliminating disparities in care, and we 
believe our proposals about QAPI and infection prevention and control 
and antibiotic stewardship programs would improve quality and promote 
consistent national standards. Our proposals regarding nursing services 
and the term ``licensed independent practitioners'' would support care 
coordination and quality of care. In sum, we believe our proposed 
changes are necessary, timely, and beneficial.

II. Provisions of the Proposed Rule

A. Patient's Rights (Sec.  482.13)

1. Non-Discrimination
    One of the basic requirements for providers who participate in the 
Medicare program is that, they must agree to meet the applicable civil 
rights requirements of Title VI of the Civil Rights Act of 1964, as 
implemented by 45 CFR part 80; section 504 of the Rehabilitation Act of 
1973, as implemented by 45 CFR part 84; the Age Discrimination Act of 
1975, as implemented by 45 CFR part 90; Section 1557 of the Patient 
Protection and Affordable Care Act of 2010 (Pub. L. 111-148) (Section 
1557); and other pertinent requirements enforced by the HHS Office for 
Civil Rights (OCR) (see 42 CFR 489.10(b)). Title VI prohibits 
discrimination based on race, color, and national origin. Section 504 
prohibits discrimination based on disability. The Age Act prohibits 
discrimination based on age. Section 1557 of the Affordable Care Act 
prohibits discrimination on all of these bases and is the first federal 
civil rights law to prohibit discrimination based on sex, including 
gender identity, in covered health programs and activities. In 
addition, the Hospital and CAH Conditions of Participation (CoPs) 
require that hospitals and CAHs be in compliance with applicable 
Federal laws related to the health and safety of patients. However, 
there is currently no explicit prohibition of discrimination contained 
within the Hospital and CAH CoPs. We have been made aware that the 
historic lack of an explicit prohibition within the CoPs, and, in 
particular, the lack of civil rights protections regarding hospital 
patients' gender identities, is regarded as having been a barrier to 
seeking care by individuals who fear such discrimination. 
Discriminatory behavior, or even the fear of discriminatory behavior, 
by healthcare providers remains an issue and can create barriers to 
care and result in adverse outcomes for patients. Numerous studies 
address the impact of discrimination or perceived discrimination on 
individuals seeking healthcare. Discrimination can be based on sexual 
orientation, racial or ethnic background, or other factors. The 
Institute of Medicine (IOM) noted in its 2011 report The Health of 
Lesbian, Gay, Bisexual, and Transgender People: Building a Foundation 
for Better Understanding that many lesbian, gay, bisexual, and 
transgender (LGBT) people refrain from disclosing their sexual 
orientation or gender identity to researchers and health care 
providers. The report goes on to note that:
    Some LGBT individuals face discrimination in the health care system 
that can lead to an outright denial of care or to the delivery of 
inadequate care. There are many examples of manifestations of enacted 
stigma against LGBT individuals by health care providers. LGBT 
individuals have reported experiencing refusal of treatment by health 
care staff, verbal abuse, and disrespectful behavior, as well as many 
other forms of failure to provide adequate care (Eliason and Schope, 
2001; Kenagy, 2005; Scherzer, 2000; Sears, 2009 as cited in Institute 
of Medicine. The Health of Lesbian, Gay, Bisexual, and Transgender 
People: Building a Foundation for Better Understanding. Washington, DC: 
The National Academies Press, 2011.)
    Perceived discriminatory behavior among African-American and white 
patients treated for osteoarthritis by orthopedic surgeons in two 
Veterans Affairs facilities negatively affected patient-provider 
communications (Leslie R.M. Hausmann, Ph.D., Michael J. Hannon, MA, 
Denise M. Kresevic, RN, Ph.D., Barbara H. Hanusa, Ph.D., C. Kent Kwoh, 
MD, and Said A. Ibrahim, MD, MPH. Med Care. 2011 July; 49(7): 626-633). 
Tracy MacIntosh et al report that racial/ethnic minorities who reported 
being socially-assigned as white are more likely to receive preventive 
vaccinations and less likely to report healthcare discrimination 
compared with those who are socially-assigned as minority. (MacIntosh 
T, Desai MM, Lewis TT, Jones BA, Nunez-Smith M (2013) Socially-Assigned 
Race, Healthcare Discrimination and Preventive Healthcare Services. 
PLoS ONE 8(5): e64522. doi:10.1371/journal.pone.0064522). In a 2012 
study, the authors found that African-American and Asian immigrant 
participants reported experiencing different forms of medical 
discrimination related to class, race, and language. (Thu Quach, Ph.D., 
MPH, Amani Nuru-Jeter, Ph.D., MPH, Pagan Morris, MPH, Laura Allen, BA, 
Sarah J. Shema, MS, June K. Winters, BA, Gem M. Le, Ph.D., MHS, and 
Scarlett Lin Gomez, Ph.D. Am J Public Health. 2012;102:1027-1034. 
doi:10.2105/AJPH.201.1300554).
    Because discriminatory behavior can affect perceived and actual 
access to and effectiveness of healthcare delivery, we propose to 
establish explicit requirements that a hospital not discriminate on the 
basis of race, color, national origin, sex (including gender identity), 
age, or disability and that the hospital establish and implement a 
written policy prohibiting discrimination on the basis of race, color, 
national origin, sex (including gender identity), age, or disability. 
We are proposing these requirements to ensure nondiscrimination as 
required by Section 1557 of the Affordable Care Act, which prohibits 
health programs and activities that receive federal financial 
assistance, such as Medicare and Medicaid, from excluding or denying 
beneficiaries participation based on

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their race, color, national origin, sex (including gender identity), 
age, or disability. In addition, we believe that discrimination by a 
hospital based on a patient's religion or sexual orientation can 
potentially lead to a denial of services or inadequate care in the 
hospital, which is detrimental to the patient's health and safety. We 
are therefore also proposing to establish explicit requirements that a 
hospital not discriminate on the basis of religion or sexual 
orientation and that a hospital establish and implement a written 
policy prohibiting discrimination on the basis of religion or sexual 
orientation. We are doing so under the statutory authority of Section 
1861(e)(9) of the Act, which specifies that a hospital ``must also meet 
other requirements as the Secretary finds necessary in the interest of 
the health and safety of individuals who are furnished services in the 
facility.'' As noted, substantial academic research demonstrates that 
discrimination on the basis of sexual orientation is inconsistent with 
the health and safety of patients, as this may lead to a denial of 
services not justified by a medically appropriate rationale.
    We propose to further require that each patient, and/or 
representative, and/or support person, where appropriate, is informed, 
in a language he or she can understand, of the right to be free from 
discrimination against them on any of these bases when he or she is 
informed of his or her other rights under Sec.  482.13. In addition, we 
propose to require that the hospital inform the patient and/or 
representative, and/or support person, on how he or she can seek 
assistance if they encounter discrimination. A patient's ``support 
person'' does not necessarily have to be the patient's representative 
who is legally responsible for making medical decisions on the 
patient's behalf. A support person could be a family member, friend, or 
other individual who is there to support the patient during the course 
of the stay. We discuss the meaning of ``support person'' in the 
preamble to the final rule, ``Medicare and Medicaid Programs: Changes 
to the Hospital and Critical Access Hospital Conditions of 
Participation To Ensure Visitation Rights for All Patients'' (75 FR 
70833, November 19, 2010).
2. Licensed Independent Practitioners
    On May 16, 2012, we published a final rule entitled ``Medicare and 
Medicaid Programs: Reform of Hospital and Critical Access Hospital 
Conditions of Participation'' (77 FR 29034). Within the section of this 
rule discussing the changes to Sec.  482.13, one commenter requested 
that CMS make a clarifying statement regarding the requirements at 
Sec.  482.13(e)(5) that would identify which practitioners could order 
restraint or seclusion in a hospital (77 FR 29043). The commenter noted 
that the current requirements use the term ``LIP'' and that this has 
been interpreted by many hospitals to mean that a physician assistant 
(PA) could not order restraint and/or seclusion. The commenter 
expressed opposition to this interpretation and suggested instead that 
CMS clarify that, where permitted by State law, a physician would be 
permitted to delegate the ordering of such measures to a physician 
assistant. The commenter also requested that CMS provide a clarifying 
statement that PAs would be authorized to order restraint and 
seclusion.
    Our response to this comment in the final rule referred to Appendix 
A of the State Operations Manual, CMS Pub. 100-07, regarding Sec.  
482.13(e)(5), which provides, ``For the purpose of ordering restraint 
or seclusion, an LIP is any practitioner permitted by State law and 
hospital policy as having the authority to independently order 
restraints or seclusion for patients.'' We also stated in our response 
in the final rule that, ``if an individual physician assistant (PA) was 
authorized by State law and hospital policy to independently order 
restraints or seclusion for patients, then that PA could do so within 
the hospital. However, since PAs have traditionally defined themselves 
as `physician-dependent' practitioners (as opposed to APRNs, who see 
themselves as independent practitioners), it is unlikely that a PA 
would be authorized by State law and hospital policy to `independently' 
order restraints or seclusions for patients (as would be likely for 
licensed independent practitioners such as physicians, APRNs, and 
clinical psychologists). The supervising physician-PA team concept (and 
PA practice dependence on the supervising physician) is supported by 
the American Academy of Physician Assistants' description of the PA 
profession:
    `Physician assistants are health professionals licensed or, in the 
case of those employed by the federal government, credentialed to 
practice medicine with physician supervision' (American Academy of 
Physician Assistants. (2009-2010). Policy Manual. Alexandria, VA.).
    Moreover, a PA would not be allowed to order restraints or 
seclusion if the only authority to do so was delegated by a physician 
since this physician-delegated authority would establish that the PA 
was not independently authorized by State law and hospital policy, 
which we stated is a prerequisite for this type of order.''
    After publication of the final rule in May of 2012, we became aware 
of the concerns of the American Academy of Physician Assistants (AAPA) 
regarding this issue, both through communications from the AAPA and 
through the AAPA's submissions in response to the Secretary's Request 
for Regulatory Issues Unfairly Impacting Rural Providers. The AAPA 
maintains that ```Licensed Independent Practitioner' is not a term used 
in the Social Security Act, nor in any other federal law,'' and that 
``the LIP terminology is, at best, confusing regarding physician 
assistants' ability to order [restraint and seclusion]; at worst, it 
restricts the ability of hospitals to utilize PAs to the extent of 
their educational preparation and scope of practice, as determined by 
state law.'' The AAPA further contends that ```independent' practice is 
not a measure of a healthcare professional's educational preparation, 
competency, or ability to provide quality medical care,'' and that 
``the LIP terminology is inconsistent with the movement toward team-
based health care delivery, as well as the need to fully utilize the 
healthcare workforce.''
    In drafting this proposed rule, we took these arguments into 
careful consideration. We also reviewed the Children's Health Act (CHA) 
of 2000 (Pub. L. 106-310), which necessitated the changes to the 
Patients' Rights CoP Sec.  482.13, as well as the 2006 final rule that 
implemented these changes, and determined that the term ``licensed 
independent practitioner'' was carried over into the CoPs from an 
earlier version of the bill that eventually became law as the CHA. The 
CHA only uses the term ``other licensed practitioner,'' dropping the 
``independent'' modifier. Taking this into consideration, we are 
proposing to delete the modifying term ``independent'' from the CoP at 
Sec.  482.13(e)(5), as well as at Sec.  482.13(e)(8)(ii), and also 
propose to revise the provision to be in keeping with the language of 
the CHA regarding restraint and seclusion orders and licensed 
practitioners. Therefore, we are proposing that Sec.  482.13(e)(5) 
would now read that the use of restraint or seclusion must be in 
accordance with the order of a physician or other licensed practitioner 
who is responsible for the care of the patient and authorized to order 
restraint or seclusion by hospital policy in accordance with State law. 
We are also proposing that Sec.  482.13(e)(8)(ii) would state that, 
after 24 hours, before writing

[[Page 39452]]

a new order for the use of restraint or seclusion for the management of 
violent or self-destructive behavior, a physician or other licensed 
practitioner who is responsible for the care of the patient and 
authorized to order restraint or seclusion by hospital policy in 
accordance with State law would have to see and assess the patient.
    Other provisions in the current requirements regarding restraint 
and seclusion use the term ``licensed independent practitioner'', and 
we are proposing to revise these provisions as well. Section 
482.13(e)(10), (e)(11), (e)(12)(i)(A), (e)(14), and (g)(4)(ii) all 
contain the term ``licensed independent practitioner.'' Therefore, we 
are proposing to change the term from ``licensed independent 
practitioner'' to simply ``licensed practitioner.'' We are also 
proposing to remove the term ``physician assistant'' from the current 
provisions at Sec.  482.13(e)(12)(i)(B) and (e)(14) because we believe 
its use in these instances distinguishes the role of PAs from other 
licensed practitioners (such as APRNs) in ways that are confusing and 
that restrict the ability of hospitals to utilize PAs to the extent of 
their educational preparation and scope of practice. The current 
requirements severely limit a PA's scope of practice in ways that 
currently do not apply to an APRN practicing under the same 
circumstances. The AAPA has noted that by limiting a PA's scope of 
practice, the CoPs create a burden for hospitals, particularly small 
hospitals, and are contrary to state laws that allow PAs to practice to 
the full extent of their training and credentialing. PAs are trained on 
a medical model that is similar in content, if not duration, to that of 
physicians. Further, PA training and education is comparable in many 
ways to that of APRNs and in some ways, more extensive. Therefore, we 
believe that PAs, like APRNs and physicians, should not have to undergo 
additional training so that they can order restraint and seclusion. 
Therefore, we are proposing to remove PAs from the two provisions noted 
above.
3. Patient Access to Medical Records
    On December 8, 2006, CMS published final regulations which 
established requirements for patient's rights in hospitals, and which 
included requirements for the confidentiality of patient records at 
Sec.  482.13(d) (71 FR 71426). Specifically, Sec.  482.13(d)(2) states 
that a patient has the right to access information contained in his or 
her clinical records within a reasonable time frame and that the 
hospital must not frustrate the legitimate efforts of individuals to 
gain access to their own medical records and must actively seek to meet 
these requests as quickly as its record keeping system permits. 
However, the requirements as they are currently written do not take 
into account that medical records may be maintained electronically, nor 
do the requirements acknowledge that a patient has the right to access 
these medical records in an electronic format. Ideally, the patient 
should be able to access their medical records in a form or format 
requested by the patient, whether electronically or in a hard copy 
format. Therefore, we are proposing to clarify the requirement at Sec.  
482.13(d)(2) to state that the patient has the right to access their 
medical records, including current medical records, upon an oral or 
written request, in the form and format requested by the individual, if 
it is readily producible in such form and format (including in an 
electronic form or format when such medical records are maintained 
electronically); or, if not, in a readable hard copy form or such other 
form and format as agreed to by the facility and the individual, within 
a reasonable time frame. OCR recently issued an FAQ document about 
medical records access clarifying that the requirement to send medical 
records to the individual is within 30 days (or 60 days if an extension 
is applicable) after receiving the request, ``however, in most cases, 
it is expected that the use of technology will enable the covered 
entity to fulfill the individual's request in far fewer than 30 days.'' 
(http://www.hhs.gov/hipaa/for-professionals/privacy/guidance/access/#newlyreleasedfaqs). Individuals who have not been provided with their 
medical records within the 30-day timeframe required by HIPAA or who 
experience other difficulties accessing their medical records can file 
a complaint with OCR at: http://www.hhs.gov/hipaa/filing-a-complaint/index.html.

B. Quality Assessment and Performance Improvement (QAPI) Program (Sec.  
482.21)

    On January 24, 2003, CMS published a final rule in the Federal 
Register entitled ``Medicare and Medicaid Programs; Hospital Conditions 
of Participation: Quality assessment and performance improvement 
(QAPI)'' (68 FR 3435). The QAPI rule set a minimum requirement that 
each hospital participating in the Medicare program systematically 
examine the quality of its services and implement specific improvement 
projects on an ongoing basis. As a result of the QAPI rule, as well as 
other efforts and advancements in the delivery of healthcare, hospitals 
have made progress toward delivering safer, high-quality care.
    The 2003 QAPI CoP final rule provided a framework to implement 
Department of Health and Human Services initiatives designed to help 
distinguish and avoid mistakes in the healthcare delivery system. The 
existing QAPI CoP requires each hospital to:
     Develop, implement, maintain, and evaluate its own QAPI 
program;
     Establish a QAPI program that reflects the complexity of 
its organization and services;
     Establish a QAPI program that involves all hospital 
departments and services and focuses on improving health outcomes and 
preventing and reducing medical errors; and
     Maintain and demonstrate evidence of its QAPI program for 
review by CMS.
    We are proposing a minor change to the program data requirements at 
Sec.  482.21(b). Currently, we require that hospitals incorporate 
quality indicator data including patient care data and other relevant 
data (for example, information submitted to, or received from, the 
hospital's Quality Improvement Organization) into their QAPI programs. 
We propose to update this requirement to reflect and capitalize on the 
wealth of important quality data available to hospitals through several 
quality data reporting programs. Specifically, we propose to require 
that the hospital QAPI program incorporate quality indicator data 
including patient care data submitted to or received from quality 
reporting and quality performance programs, including but not limited 
to data related to hospital readmissions and hospital-acquired 
conditions. Most hospitals collect and analyze data for several quality 
reporting and quality performance programs, such as the Hospital 
Inpatient Quality Reporting program, the Hospital Value-Based 
Purchasing Program, the Hospital-Acquired Condition Reduction Program, 
the Medicare and Medicaid Electronic Health Record Incentive Programs, 
and the Hospital Outpatient Quality Reporting program. Since a hospital 
is already collecting and reporting quality measures data for these 
programs, we believe that it is efficient and cost-effective for a 
hospital to include at least some of these data in its QAPI program. 
The data are used to calculate measures, which are generally endorsed 
by the National Quality Forum (NQF). We believe the resulting data are 
a valuable resource to hospitals that should be used in hospital QAPI 
programs.
    While we are not proposing to require that hospitals develop and 
implement information technology (IT) systems as

[[Page 39453]]

part of their QAPI program, we encourage hospitals to use IT systems, 
including systems to exchange health information with other providers, 
that are designed to improve patient safety and quality of care. In 
addition, we believe that those facilities that are electronically 
capturing information should be doing so using certified health IT that 
will enable real time electronic exchange with other providers. By 
using certified health IT, facilities can ensure that they are 
transmitting interoperable data that can be used by other settings, 
supporting a more robust care coordination and higher quality of care 
for patients.

C. Nursing Services (Sec.  482.23)

    As a result of our internal review of the CoPs for nursing 
services, we recognized that some of our requirements might be 
ambiguous and confusing due to unnecessary distinctions between 
inpatient and outpatient services, or might fail to account for the 
variety of ways through which a hospital might meet its nurse staffing 
requirements. We propose to make revisions to the nursing services CoP 
to improve clarity. Specifically, we propose to revise Sec.  482.23(b), 
which currently states that there must be supervisory and staff 
personnel for each department or nursing unit to ensure, when needed, 
the immediate availability of a registered nurse for bedside care of 
any patient. We propose to delete the term ``bedside,'' which might 
imply only inpatient services to some readers. The nursing service must 
ensure that patient needs are met by ongoing assessments of patients' 
needs and must provide nursing staff to meet those needs regardless of 
whether the patient is an inpatient or an outpatient. There must be 
sufficient numbers, and types of supervisory and staff nursing 
personnel to respond to the appropriate nursing needs and care of the 
patient population of each department or nursing unit. When needed, a 
registered nurse must be available to care for any patient. We 
understand that the term ``immediate availability'' has been 
interpreted to mean physically present on the unit or in the 
department. We further understand that there are some outpatient 
services where it might not be necessary to have a registered nurse 
physically present. For example, while it is clearly necessary to have 
an RN present in an outpatient ambulatory surgery recovery unit, it 
might not be necessary to have an RN on-site at an off-campus MRI 
facility at Sec.  482.23(b)(7). We propose to allow a hospital to 
establish a policy that would specify which, if any, outpatient 
departments would not be required to have an RN physically present as 
well as the alternative staffing plans that would be established under 
such a policy. We would require such a policy to take into account 
factors such as the services delivered, the acuity of patients 
typically served by the facility, and the established standards of 
practice for such services. In addition, we would propose that the 
policy must be approved by the medical staff and be reviewed at least 
once every three years. We welcome comments on the need for, the risks 
of establishing, and the appropriate criteria we should require for 
such an exception.
    We also propose to clarify in paragraph (b)(4) (which currently 
requires that the hospital must ensure that the nursing staff develops, 
and keeps current, a nursing care plan for each patient and that the 
plan may be part of an interdisciplinary care plan) that while a 
nursing care plan is needed for every patient, the care plan should 
reflect the needs of the patient and the nursing care to be provided to 
meet those needs. The care plan for a patient with complex medical 
needs and a longer anticipated hospitalization may be more extensive 
and detailed than the care plan for a patient with a less complex 
medical need expecting only a brief hospital stay. We expect that a 
nursing care plan would be initiated and implemented in a timely 
manner, include patient goals as part of the patient's nursing care 
assessment and, as appropriate, physiological and psychosocial factors 
(such as specific physical limitations and available support systems), 
physical and behavioral health comorbidities, and patient discharge 
planning. In addition, it should be consistent with the plan for the 
patient's medical care and demonstrate evidence of reassessment of the 
patient's nursing care needs, response(s) to nursing interventions, 
and, as needed, revisions to the plan.
    Finally, we propose to revise paragraph (b)(6) (which currently 
states that non-employee licensed nurses working in the hospital must 
adhere to the policies and procedures of the hospital and that the 
director of nursing service must provide for the adequate supervision 
and evaluation of the clinical activities of non-employee nursing 
personnel) to clarify that all licensed nurses who provide services in 
the hospital must adhere to the policies and procedures of the 
hospital. In addition, the director of nursing service must provide for 
the adequate supervision and evaluation of the clinical activities of 
all nursing personnel (that is, all licensed nurses and any non-
licensed personnel such as nurse aides, orderlies, or other nursing 
support personnel who are under the direction of the nursing service) 
which occur within the responsibility of the nursing service, 
regardless of the mechanism through which those personnel are obtained. 
We recognize that there are a variety of arrangements under which 
hospitals obtain the services of licensed nurses. Mechanisms may 
include direct employment, the use of contract or agency nurses, a 
leasing agreement, volunteer services or some other arrangement. No 
matter how the services of a licensed nurse are obtained, in order to 
ensure the health and safety of patients, all nurses must know and 
adhere to the policies and procedures of the hospital and there must be 
adequate supervision and evaluation of the clinical activities of all 
nursing personnel who provide services that occur within the 
responsibility of the nursing service. We would expect non-licensed 
personnel to be supervised by a licensed nurse.
    In addition, we propose to delete inappropriate references to Sec.  
482.12(c) that are currently in paragraphs (c)(1) and (3). We discuss 
these technical corrections in detail below.

D. Medical Record Services (Sec.  482.24)

    The Medicare hospital CoPs apply to services being provided to all 
patients, regardless of insurer, and to both inpatients and outpatients 
of a hospital. However, some of the regulatory language in the Medical 
Record Services CoP (Sec.  482.24) appears to apply to only inpatients, 
particularly with the use of terms such as ``admission,'' 
``hospitalization,'' and ``discharge.'' We are proposing to make 
changes to several of the provisions in this CoP so that the 
requirements are clearer regarding the distinctions between a patient's 
inpatient and outpatient status and the subtle differences between 
certain aspects of medical record documentation related to each status.
    The current requirements at Sec.  482.24(c) state that the content 
of the medical record must contain information to justify admission and 
continued hospitalization, support the diagnosis, and describe the 
patient's progress and response to medications and services. While we 
believe that these terms are appropriate for inpatients, they do not 
fully capture the specific documentation necessary for outpatients. For 
example, appropriate documentation for an outpatient would be a current 
progress note, often in the accepted standard of a SOAP (Subjective, 
Objective, Assessment, Plan) note. Therefore, we propose to

[[Page 39454]]

revise the current regulatory language to require that the content of 
the medical record must contain information to justify all admissions 
and continued hospitalizations, support the diagnoses, describe the 
patient's progress and responses to medications and services, and 
document all inpatient stays and outpatient visits to reflect all 
services provided to the patient.
    Similarly, we propose to revise Sec.  482.24(c)(4)(ii) from the 
current requirement for documentation of ``admitting diagnosis'' to 
include ``all diagnoses specific to each inpatient stay and outpatient 
visit,'' which would include specifying any admitting diagnoses. Within 
this same standard, we are proposing to update several terms to reflect 
more current terminology and standards of practice. Therefore, at Sec.  
482.24(c)(4)(iv), we propose to require that the content of the record 
include documentation of complications, hospital-acquired conditions, 
healthcare-associated infections, and adverse reactions to drugs and 
anesthesia. We also propose changes to Sec.  482.24(c)(4)(vi) to add 
``progress notes . . . interventions, responses to interventions . . . 
'' to the required documentation of ``practitioners' orders'' to 
emphasize the necessary documentation for both inpatients and 
outpatients. And we propose to add the phrase ``to reflect all services 
provided to the patient,'' so that the entire provision would now read 
that the content of the record must contain all practitioners' progress 
notes and orders, nursing notes, reports of treatment, interventions, 
responses to interventions, medication records, radiology and 
laboratory reports, and vital signs and other information necessary to 
monitor the patient's condition and to reflect all services provided to 
the patient.
    Continuing under this standard detailing the contents of the 
medical record, we propose to make revisions to the final two 
provisions under this standard. We propose to change Sec.  
482.24(c)(4)(vii) to require that all patient medical records must 
document discharge and transfer summaries with outcomes of all 
hospitalizations, disposition of cases, and provisions for follow-up 
care for all inpatient and outpatient visits to reflect the scope of 
all services received by the patient. We believe that these changes 
would clarify the importance of discharge summaries for patients being 
discharged home as well as the importance of transfer summaries for 
patients being transferred to post-acute care facilities such as 
nursing homes or inpatient rehabilitation facilities. In addition, we 
recognize the distinction between the services received by inpatients 
and those received by outpatients by proposing to include language that 
distinguishes between the inpatient and the outpatient experiences.
    Finally, we emphasize the distinctions between discharges and 
transfers as well as between inpatients and outpatients by proposing to 
revise Sec.  482.24(c)(4)(viii) so that the content of the medical 
record would contain final diagnoses with completion of medical records 
within 30 days following all inpatient stays, and within 7 days 
following all outpatient visits.

E. Infection Prevention and Control and Antibiotic Stewardship Programs 
(Sec.  482.42)

Background
    CMS introduced Infection Control as a hospital CoP in 1986 amidst 
growing recognition that infections and communicable diseases were 
potentially exposing hospital patients to significant pain and risk, 
and driving up direct hospital charges (51 FR 22010, 22027). The 
regulation increased hospital accountability and sought to ensure that 
hospitals identify, prevent, control, investigate, and report 
infections and communicable diseases of patients and hospital 
personnel. The regulation also established a requirement for hospitals 
to keep a log to identify problems and for improvement to be made when 
problems were identified.
    The Infection Control CoP has essentially remained unchanged in its 
regulatory form, notwithstanding a final rule published in May 2012, 
``Reform of Hospital and Critical Access Hospital Conditions of 
Participation'' (77 FR 29034), which removed the obsolete and redundant 
requirement for hospitals to maintain infection control logs, since 
hospitals are already required to monitor infections and currently do 
so through various surveillance methods, including electronic systems. 
The final rule also made a technical change to the CoP and replaced the 
outdated term, ``quality assurance program,'' with the more current 
term, ``quality assessment and performance improvement program.''
    The Department of Health and Human Services is particularly 
concerned about HAIs, as they are a significant cause of morbidity and 
mortality in the United States. In 2011, there were an estimated 
722,000 cases of HAIs in US hospitals with 75,000 inpatients with HAIs 
that died during that same time period (Magill SS, Edwards JR, Bamberg 
W et al. Multistate Point Prevalence Survey of Health Care-Associated 
Infections. New England Journal of Medicine 2014; 370:1198-208.) 
Additionally, HHS is concerned about the growing threat to patient 
safety posed by organisms that are resistant to antibiotics, referred 
to as ``multi-drug resistant organisms (MDROs).'' Options for treating 
patients with MDRO infections are very limited, resulting in increased 
mortality, as well as increased hospital lengths of stay and costs. In 
response, HHS launched an Action Plan in April 2013 toward the 
prevention and elimination of HAIs. (HHS. ``HHS Action Plan to Prevent 
Healthcare-Associated Infections.'' Accessed 5 March 2014 http://www.hhs.gov/ash/initiatives/hai/actionplan/index.html.) The HHS Action 
Plan identifies policy changes, some addressed here in this proposed 
rule, in an effort to provide better, more efficient care.
    We are proposing revisions to Sec.  482.42 in an effort to further 
clarify existing requirements and update regulatory language to reflect 
state-of-the-art practices and terminology. We are also proposing 
revisions that would require a hospital to develop and maintain an 
antibiotic stewardship program as an effective means to improve 
hospital antibiotic-prescribing practices and curb patient risk for 
possibly deadly Clostridium difficile infections (CDIs), as well as 
other future, and potentially life-threatening, antibiotic-resistant 
infections. We would promote better alignment of a hospital's infection 
control and antibiotic stewardship efforts with nationally recognized 
guidelines and heighten the role and accountability of a hospital's 
governing body in program implementation and oversight. We believe that 
these changes, together, would promote a more patient-centered culture 
of safety focused on infection prevention and control as well as 
appropriate antibiotic use, while allowing hospitals the flexibility to 
align their programs with the guidelines best suited to them.
Summary of Changes to Sec.  482.42
    In its present form, the ``Infection Control'' CoP set forth at 
Sec.  482.42 requires hospitals to provide a sanitary environment to 
avoid sources and transmission of infections and communicable diseases. 
Hospitals are presently required to have a designated infection control 
officer, or officers, who are required to develop a system to identify, 
report, investigate and control infections and communicable diseases of 
patients and personnel. The hospital's CEO, medical staff, and director 
of nursing services are charged with ensuring that the problems

[[Page 39455]]

identified by the infection control officer or officers are addressed 
in hospital training programs and their QAPI program. The CEO, medical 
staff, and director of nursing services are also responsible for the 
implementation of successful corrective action plans in affected 
problem areas.
    At the outset, we propose a change to the title of this CoP to 
``Infection prevention and control and antibiotic stewardship 
programs.'' By adding the word ``prevention'' to the CoP name, our 
intent is to promote larger, cultural changes in hospitals such that 
prevention initiatives are recognized on balance with their current, 
traditional control efforts. And by adding ``antibiotic stewardship'' 
to the title, we would emphasize the important role that a hospital 
should play in combatting antimicrobial resistance through 
implementation of a robust stewardship program that follows nationally 
recognized guidelines for appropriate antibiotic use. Along with these 
changes, we propose to change the introductory paragraph to require 
that a hospital's infection prevention and control and antibiotic 
stewardship programs be active and hospital-wide for the surveillance, 
prevention, and control of HAIs and other infectious diseases, and for 
the optimization of antibiotic use through stewardship. We would also 
require that a program demonstrate adherence to nationally recognized 
infection prevention and control guidelines for reducing the 
transmission of infections, as well as best practices for improving 
antibiotic use, for reducing the development and transmission of HAIs 
and antibiotic-resistant organisms. While these particular changes are 
new to the regulatory text, it is worth noting that these requirements, 
with the exception of the new requirement for an antibiotic stewardship 
program, have been present in the Interpretive Guidelines for hospitals 
since 2008 (See A0747 at Appendix A--Survey Protocol, Regulations and 
Interpretive Guidelines for Hospitals, http://cms.gov/manuals/Downloads/som107ap_a_hospitals.pdf).
    We also propose to introduce the term ``surveillance'' into the 
text of the regulation. The addition of this term, which is also 
already in use in CMS Interpretive Guidelines for hospitals, is being 
proposed to bring the regulation up to date by reflecting current 
terminology in the field. As has been described in the Interpretive 
Guidelines for this regulation, ``surveillance'' includes infection 
detection, data collection, and analysis, monitoring, and evaluation of 
preventive interventions. (See SOM, Appendix A--Survey Protocol, 
Regulations and Interpretive Guidelines for Hospitals, pp.361-362, 
http://cms.gov/manuals/Downloads/som107ap_a_hospitals.pdf.) 
Surveillance practices include sampling or other mechanisms to permit 
identifying and monitoring infections occurring throughout the 
hospitals various locations or departments. In accordance with proposed 
Sec.  482.42(c)(2)(ii), the hospital would be required to document its 
surveillance activities. Such documentation would likely include the 
measures selected for monitoring, and collection of data and analysis 
methods. Just as we would for other parts of the hospital's infection 
prevention and control program, we would require surveillance 
activities to be conducted in accordance with nationally recognized 
infection control surveillance practices, such as the widely accepted 
CDC National Healthcare Safety Network (NHSN). In collaboration with 
the hospital's QAPI program, the hospital would be required to develop 
and implement appropriate infection prevention and control 
interventions to address issues identified through its detection 
activities. Hospitals are encouraged to have mechanisms in place for 
the early identification of patients with targeted MDROs prevalent in 
their hospital and community, and for the prevention of transmission of 
such MDROs. When ongoing transmission of targeted MDROs in the hospital 
is identified, the infection prevention and control program would use 
this event to identify potential breaches in infection control 
practice.
    As has previously been suggested in Interpretive Guidance, 
surveillance could also include ``automated surveillance'' by way of 
analyzing useful information from infection control data through the 
systematic application of medical informatics and computer science 
technologies. (See also Wright, M. Automated Surveillance and Infection 
Control: Toward a better tomorrow. Am J Infect Control 2008; 36:S1-S5.) 
Automated surveillance includes, but is not limited to, either data 
mining (discovering patterns and relationships which can be used to 
classify and predict) or query-based data management (requires user 
input, but does not seek patterns independently). A variety of 
automated systems exist and include both commercial and hospital-
designed systems which, at a minimum, integrate portions of the medical 
record with laboratory, admission, discharge, transfer, and treatment 
information.
    We are also proposing a new requirement that hospitals demonstrate 
adherence to nationally recognized infection prevention and control 
guidelines, as well as best practices for improving antibiotic use, 
where applicable, for reducing the development and transmission of HAIs 
and antibiotic-resistant organisms. We realize that, in developing the 
patient health and safety requirements that are the hospital CoPs, 
particular attention must be paid to the ever-evolving nature of 
medicine and patient care. Moreover, a certain degree of latitude must 
be left in the requirements to allow for innovations in medical 
practice that improve the quality of care and move toward the reduction 
of medical errors and patient harm.
    We are proposing to intentionally build flexibility into the 
regulation by proposing language that requires hospitals to demonstrate 
adherence to nationally recognized guidelines rather than any specific 
guideline or set of guidelines for infection prevention and control and 
for antibiotic stewardship. While the CDC guidelines represent one set, 
there are other sets of nationally recognized guidelines from which 
hospitals might choose, such as those established by SHEA and IDSA. We 
believe this approach would provide hospitals the flexibility they need 
to select and integrate those standards that best suit their individual 
infection prevention and control and antibiotic stewardship programs. 
We also believe this approach would allow hospitals the flexibility to 
adapt their policies and procedures in concert with any updates in the 
guidelines they have elected to follow.
Sec.  482.42(a) Standard: Infection Prevention and Control Program 
Organization and Policies
    We propose substantive changes to Sec.  482.42(a), which sets forth 
the standard on ``Organization and policies.'' First, we propose a 
change in the title of this standard that would now read, ``Infection 
prevention and control program organization and policies.'' Current 
requirements pertaining to an infection control officer or officers 
would be amended within Sec.  482.42(a) and some would be moved to 
Sec.  482.42(c)(2).
Sec.  482.42(a)(1) Infection Control Officer(s)
    Specifically, at Sec.  482.42(a)(1), we propose to require the 
hospital to appoint an infection preventionist(s)/infection control 
professional(s). Within this proposed change we are deleting the 
outdated term, ``infection control officer,'' and replacing it with the 
more current and accurate terms, ``infection

[[Page 39456]]

preventionist/infection control professional.'' CDC has defined 
``infection control professional (ICP)'' as ``a person whose primary 
training is in either nursing, medical technology, microbiology, or 
epidemiology and who has acquired specialized training in infection 
control.'' In designating infection preventionists/ICPs, hospitals 
should ensure that the individuals so designated are qualified through 
education, training, experience, or certification (such as that offered 
by the Certification Board of Infection Control and Epidemiology Inc. 
(CBIC), or by the specialty boards in adult or pediatric infectious 
diseases offered for physicians by the American Board of Internal 
Medicine (for internists) and the American Board of Pediatrics (for 
pediatricians)). Infection preventionists/ICPs should maintain their 
qualifications through ongoing education and training, which can be 
demonstrated by participation in infection control courses, or in local 
and national meetings, organized by recognized professional societies, 
such as Association for Professionals in Infection Control and 
Epidemiology (APIC), Association of periOperative Registered Nurses 
(AORN), Society for Healthcare Epidemiology of America (SHEA), and the 
Infectious Diseases Society of America (IDSA).
    We would also require hospitals to seek out and consider the 
recommendations of medical staff leadership and nursing leadership in 
making such appointments. The proposed requirement would be a subtle, 
but important, departure from the current requirement at Sec.  
482.42(a), which simply requires that an officer or officers be 
designated to implement and develop the program. We believe our 
proposed approach would require high-level hospital clinical 
leadership, such as those individuals responsible for the medical staff 
and for the nursing service, be involved in the process of selecting 
the infection preventionists/ICPs, and is in keeping with our aim of 
promoting a hospital-wide culture of safety and quality in which input 
across the hospital is solicited and acted upon.
    While we are proposing a change to the qualifications for infection 
preventionists/ICPs, we wish to highlight that the other requirements 
for designating an individual or individuals would remain otherwise 
unchanged. A hospital can still designate one or more individuals to 
fulfill the responsibilities within an infection prevention and control 
program. In a setting with multiple infection preventionists/ICPs, we 
would expect them to work together as an integrated team. What is 
important is that the functions of an infection prevention and control 
program are covered; it is not necessary for all functions to rest with 
one individual.
Sec.  482.42(a)(2) Preventing and Controlling the Transmission of 
Infections Within the Hospital and Between the Hospital and Other 
Institutions and Settings
    We have proposed language at Sec.  482.42(a)(2) that would adjust 
the scope of the hospitals' prevention and control programs from its 
current focus on transmission of infections between ``patients and 
personnel'' by proposing a focus on ``transmission of infection'' in 
the broader sense. This change is intended to reflect the efforts 
hospitals must make to prevent and control infections not just between 
patients and personnel, but also between individuals across the entire 
hospital setting (for example, among patients, personnel, and visitors) 
as well as between the hospital and other healthcare institutions and 
settings and between patients and the healthcare environment. In the 
case of transmission of infections within the hospital, we would expect 
hospitals to consider the impact of their outpatient facilities on 
their inpatient units. We would expect hospitals to look to guidelines, 
such as those summarized by the CDC in its recent publication, ``Guide 
to Infection Prevention for Outpatient Settings: Minimum Expectations 
for Safe Care.'' (CDC. ``Guide to Infection Prevention for Outpatient 
Settings'' Accessed 18 November 2015 http://www.cdc.gov/HAI/settings/outpatient/outpatient-care-guidelines.html).
    We believe this section reflects current best practices that are in 
place in most hospitals. The reality is that patients move between 
settings with great frequency and carry organisms with them, hence it 
is imperative that hospitals approach multi-drug resistant organism 
control from the broader perspective in order to protect their patients 
and staff. A concrete example of this already being part of current 
practice is that hospitals are already required to track both hospital- 
and community-onset cases of CDI, because research has shown that 
community-onset cases of CDI can impact hospitals. Likewise, the role 
of the environment is being increasingly recognized as an important 
source of infections and this change simply reflects this data and best 
practices. There are many good examples of hospitals working on 
preventing the spread of infection between healthcare environments. 
This update also fits with the clarification that these CoPs apply to 
both a hospital's inpatient and outpatient locations.
Sec.  482.42(a)(3) Healthcare-Associated Infections (HAIs)
    In this proposed rule, we are also expanding the focus on and the 
awareness of the sources of HAIs that a hospital must address through 
its infection prevention and control program. We believe this change is 
appropriate given the rise in HAIs related to inter-facility transfer 
of patients, as people move through the system and across the continuum 
of health care. Given the number of facilities through which a patient 
might travel, our proposal to increase the involvement of hospital 
infection prevention and control programs would facilitate 
communication across settings. The provision would also require the 
program to address any infection control issues identified by public 
health authorities. Hospitals could look to the HHS Action Plan to 
Prevent Healthcare-Associated Infections as a resource for identifying 
prominent HAIs. (HHS. ``HHS Action Plan to Prevent Healthcare-
Associated Infections.'' Accessed 3 August 2011 http://www.hhs.gov/ash/initiatives/hai/actionplan/index.html).
    Hospitals could also find it helpful to refer to the list (which 
features several categories of HACs and includes specific types of 
HAIs) that CMS publishes annually in its FY 2016 Inpatient Prospective 
Payment System final rule (80 FR 49325), in accordance with section 
5001(c) of the Deficit Reduction Act (DRA) of 2005.
Sec.  482.42(a)(4) Scope and Complexity
    We also propose to add a requirement at Sec.  482.42(a)(4) to 
clarify that we would expect hospitals to develop and manage an 
infection prevention and control program that ``reflects the scope and 
complexity of the hospital services provided.'' For example, a hospital 
that offers surgical services (contrasted with a hospital that does not 
offer surgical services) would be expected to have an infection 
prevention and control program that addresses infection issues specific 
to the surgical patient. Also, the CDC's Healthcare Infection Control 
Practices Advisory Committee (HICPAC), as well as professional 
infection control organizations such as APIC and SHEA, publish studies 
and recommendations on resource allocation that hospitals might find 
useful.

[[Page 39457]]

Sec.  482.42(b) Standard: Antibiotic Stewardship Program Organization 
and Policies
    We propose a new standard at Sec.  482.42(b) titled, ``Antibiotic 
stewardship program organization and policies,'' in order to require 
hospitals to have policies and procedures for, and to demonstrate 
evidence of, an active and hospital-wide antibiotic stewardship 
program. Antibiotic stewardship, as an area of infection control, has 
long been recognized as one of the special challenges that hospitals 
must meet in order to address the problems of multidrug-resistant 
organisms and CDIs in hospitals.
    As part of the antibiotic stewardship program, we propose that 
hospitals would be required to improve their internal coordination 
among all components responsible for antibiotic use and reducing the 
development of resistance, including, but not limited to, the infection 
prevention and control program, the QAPI program, the medical staff, 
nursing services, and pharmacy services. We also propose a requirement 
for hospitals to promote evidence-based use of antibiotics, and to 
reduce the incidence of adverse consequences of inappropriate 
antibiotic use including, but not limited to, CDIs and growth of 
antibiotic resistance in the hospital overall. CMS believes that the 
proposed requirement for a hospital to implement and maintain an active 
and hospital-wide antibiotic stewardship program will prove to be an 
effective means to improve hospital antibiotic-prescribing practices 
and thereby curb patient risk for potentially life-threatening, 
antibiotic-resistant infections, including CDI. We also believe that a 
robust antibiotic stewardship program that is coordinated with the 
hospital's overall infection prevention and control program might 
provide a synergistic approach to addressing HAIs and antibiotic 
resistance. In a November 2013 report entitled ``Appropriate Use of 
Medical Resources,'' the American Hospital Association lists antibiotic 
stewardship as one of the top five ways that hospitals can improve the 
use of their medical resources (Combes J.R. and Arespacochaga E., 
Appropriate Use of Medical Resources. American Hospital Association's 
Physician Leadership Forum, Chicago, IL. November 2013.).
    Further supporting this call for hospital AS programs, CDC recently 
issued a detailed study through its Morbidity and Mortality Weekly 
Report (MMWR) released March 7, 2014 that found that antibiotic 
prescribing for inpatients is common, and that there is ample 
opportunity to improve use and patient safety by reducing incorrect and 
inappropriate antibiotic prescribing (http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6309a4.htm?s_cid=mm6309a4_w Accessed March 14, 2014). Prior 
to the release of this study on MMWR, CDC also issued early releases of 
this information on both its Vital Signs and Get Smart for Healthcare 
sites (http://www.cdc.gov/vitalsigns/antibiotic-prescribing-practices/index.html; http://www.cdc.gov/getsmart/healthcare/ both accessed March 
4, 2014.). According to these reports:
     About one-third of the time, in prescribing the critical 
and common drug vancomycin and in the treatment of common urinary tract 
infections, patients were given antibiotics without proper testing or 
evaluation, were given drugs for too long, or were given antibiotics 
when evidence suggested they were not needed at all.
     Clinicians in some hospitals prescribed three times as 
many antibiotics as clinicians in other hospitals, even though patients 
were receiving care in similar areas of each hospital. This difference 
suggests the need to improve prescribing practices.
     A 30 percent reduction in the broad-spectrum antibiotics 
most likely to cause CDI could reduce these deadly infections by 26 
percent.
    Additionally and prior to CMS drafting this proposed rule, the 
Infectious Disease Society of America (IDSA) and SHEA wrote a letter to 
CMS (dated March 4, 2014) detailing ``the supportive evidence and 
rationale to adopt Antimicrobial Stewardship (AS) as a Medicare 
Condition of Participation (CoP).'' In the letter, IDSA and SHEA define 
``antibiotic stewardship'' as ``the optimal use of antimicrobials to 
achieve the best clinical outcomes while minimizing adverse events, 
limiting factors that lead to antimicrobial resistance, and reducing 
excessive costs attributable to suboptimal antimicrobial use.'' They 
presented extensive evidence for the value that antibiotic stewardship 
programs could hold for patients and hospitals as well as for the 
overall healthcare system. The letter cited numerous studies that 
demonstrated that ``AS programs provide significant cost savings or at 
least offset the cost of AS programs through reduction in drug 
acquisition costs, correlating with improved clinical outcomes.'' 
(http://www.shea-online.org/View/ArticleId/265/SHEA-IDSA-letter-to-CMS-advancing-Antimicrobial-Stewardship-as-a-Condition-of-Participation.aspx)
    As is the case for infection prevention and control programs, we 
believe there should be flexibility in how antibiotic stewardship 
programs are implemented. Guidance on best practices for implementing 
antibiotic stewardship programs is available from several 
organizations, including IDSA, SHEA, the American Society for Health 
System Pharmacists, and CDC.\1\
---------------------------------------------------------------------------

    \1\ ``Antimicrobial Agent Use''. http://www.idsociety.org/Antimicrobial_Agents/. ``Antimicrobial Stewardship: Guidelines''. 
http://www.shea-online.org/PriorityTopics/AntimicrobialStewardship/Guidelines.aspx. ``Antimicrobial Stewardship Resources''. http://www.ashp.org/menu/PracticePolicy/ResourceCenters/Inpatient-Care-Practitioners/Antimicrobial-Stewardship. ``Core Elements of Hospital 
Antibiotic Stewardship Programs'' http://www.cdc.gov/getsmart/healthcare/implementation/core-elements.html.
---------------------------------------------------------------------------

    Taken as a whole, the studies and the supportive evidence show 
overwhelmingly that hospital AS programs can be implemented in all 
hospitals and would, as IDSA and SHEA state in their letter, ``better 
patient care, improve outcomes, and lower the healthcare costs 
associated with antibiotic overuse (that is, expenditures on 
antibiotics) as well as costs associated with infections and 
antimicrobial resistance.'' Based on this evidence, we are proposing 
the requirement for hospitals to include AS programs as integral parts 
of their overall infection prevention and control efforts.
Sec.  482.42(b)(1) Leader of the Antibiotic Stewardship Program
    We propose a new provision at Sec.  482.42(b)(1) that would require 
the hospital, with the recommendations of the medical staff leadership 
and pharmacy leadership, to designate an individual, who is qualified 
through education, training, or experience in infectious diseases and/
or antibiotic stewardship, as the leader of the antibiotic stewardship 
program. We believe that the importance of the antibiotic stewardship 
program to the hospital is great enough to warrant the leadership of a 
qualified individual, who would serve as the counterpart to his or her 
colleague(s) leading the hospital's overall infection prevention and 
control program. The skills needed to lead each program are different. 
Infection prevention programs are often led by nursing staff who do not 
prescribe antibiotics. Antibiotic stewardship programs are led by 
physicians and pharmacists who have direct knowledge and experience 
with antibiotic prescribing. However, the ultimate goals of the 
programs on preventing healthcare complications

[[Page 39458]]

like CDI and resistance are common and hence there is the need for 
collaboration. We believe that it is important for the overall success 
of both programs (and for the hospital) that each has its own distinct 
structure and leadership responsibilities, but that each works in close 
collaboration with the other.
Sec.  482.42(b)(2)(i), (ii), and (iii) Meeting the Goals of the 
Antibiotic Stewardship Program
    Proposed requirements at Sec.  482.42(b) would require the hospital 
to ensure that the following goals for an AS program are met: (1) 
Demonstrate coordination among all components of the hospital 
responsible for antibiotic use and factors that lead to antimicrobial 
resistance, including, but not limited to, the infection prevention and 
control program, the QAPI program, the medical staff, nursing services, 
and pharmacy services; (2) document the evidence-based use of 
antibiotics in all departments and services of the hospital; and (3) 
demonstrate improvements, including sustained improvements, in proper 
antibiotic use, such as through reductions in CDI and antibiotic 
resistance in all departments and services of the hospital. We believe 
that these components are essential for a robust and effective AS 
program. After this rule is finalized, CMS will develop Interpretive 
Guidelines that will instruct surveyors on how to determine hospital 
compliance with these goals.
Sec.  482.42(b)(3) and (4) Meeting Nationally Recognized Guidelines; 
and Scope and Complexity
    Three new provisions would require the hospital ensure that the AS 
program adheres to nationally recognized guidelines, as well as best 
practices, for improving antibiotic use, and, similar to the 
requirements proposed for the hospital's infection prevention and 
control program at Sec.  482.42(a)(4), the hospital also ensures that 
the AS program reflects the scope and complexity of services offered.
Sec.  482.42(c) Leadership Responsibilities
    We propose to revise the requirements currently at Sec.  482.42(b), 
``Leadership responsibilities,'' by proposing a new standard at Sec.  
482.42(c) that would enhance the accountability of hospital leadership 
for the infection prevention and control and antibiotic stewardship 
programs as well as delineate the responsibilities for the leaders of 
the infection prevention and control program and the AS program 
respectively. We wish to promote a hospital-wide culture of safety and 
quality, and we are proposing these regulatory changes to introduce a 
catalyst at the leadership level. We believe these changes would result 
in the implementation of successful programs such as Executive Walk 
Rounds (EWRs), instituted by Brigham & Women's Hospital in Boston some 
years ago. The goals of these rounds (and others modeled on them) are 
to: Ensure safety is a high priority for senior leadership; increase 
staff awareness of safety issues; educate staff about patient safety 
concepts such as non-punitive reporting; and obtain information from 
staff about safety issues. We also propose to update the requirements 
by adopting a broader reference to ``nursing leadership'' rather than 
``the director of nursing services,'' which is used in the current 
regulation. In addition to consultation with nursing leadership, we 
would also require hospital governing body consultation with medical 
staff, pharmacy leadership, the infection preventionist(s)/infection 
control professional(s), and the leader of the antibiotic stewardship 
program. We believe these changes would provide hospitals with greater 
flexibility and open up the process and expand accountability and 
involvement at all levels.
Sec.  482.42(c)(1) The Governing Body
    We propose requirements at Sec.  482.42(c)(1) that provide greater 
specificity with respect to the responsibilities of hospital leadership 
at the governing body level. As previously set forth, we believe these 
changes are necessary to the hospital-wide culture of quality 
improvement we are promoting.
Sec.  482.42(c)(1)(i) Governing Body Responsibilities
    In particular, we would require at Sec.  482.42(c)(1)(i) that the 
governing body ensure that systems are in place and are operational for 
the tracking of all infection surveillance, prevention, and control, 
and antibiotic use activities, in order to demonstrate the 
implementation, success, and sustainability of such activities.
Sec.  482.42(c)(1)(ii) Governing Body Responsibilities (Cont.)
    We are proposing at Sec.  482.42(c)(1)(ii) that the governing body 
ensure that all HAIs and other infectious diseases identified by the 
infection prevention and control program as well as antibiotic use 
issues identified by the antibiotic stewardship program are addressed 
in collaboration with hospital QAPI leadership. As discussed, we 
believe that a closer, more streamlined connection between infection 
prevention and control and antibiotic stewardship programs with 
hospitals' QAPI programs will translate to better quality and healthier 
patients. Ultimately, better quality and healthier patients reduce 
burden and create efficiencies in health care overall.
Sec.  482.42(c)(2) The Infection Preventionists/Infection Control 
Professionals
    At Sec.  482.42(c)(2), we establish the responsibilities of the 
infection preventionist(s)/infection control professional(s) for the 
hospital's infection prevention and control program.
Sec.  482.42(c)(2)(i) The Infection Preventionists'/Infection Control 
Professionals' Responsibilities
    We propose to add a requirement at Sec.  482.42(c)(2)(i) that would 
make the infection preventionist(s)/infection control professional(s) 
responsible for the development and implementation of hospital-wide 
infection surveillance, prevention, and control policies and procedures 
that adhere to nationally recognized guidelines. Current CMS 
Interpretive Guidelines (SOM, Appendix A, p. 353) for hospitals already 
guide hospitals to follow nationally recognized infection control 
practices or guidelines. This proposed requirement notwithstanding, we 
recognize and appreciate that a hospital might wish to implement safety 
practices as part of an investigation aimed to improve or modify 
accepted standards of infection prevention and control practice, but 
which have not yet been established as national guidelines or even 
emerged from the traditional peer review process. We do not intend to 
discourage these investigational methodologies or approaches. We would, 
however, expect to see the hospitals engaging in these sorts of 
innovative practices to also have an adequate program rooted in the 
traditional evidence-based model. There are ample recognized evidence-
based approaches for hospitals to follow, and we believe our proposed 
requirement for hospitals to adhere to nationally recognized guidelines 
would not impede any hospital's ability to otherwise make progress in 
infection prevention and control.
    Research tells us that healthcare-associated infections are one of 
the most preventable causes of mortality in the United States (U.S.). 
For example, in a seminal study on central line-associated bloodstream 
infections (CLABSIs), known as the Michigan Keystone study, researchers 
demonstrated the profound impact that the use of checklists can

[[Page 39459]]

have when applied to the medical field. The study demonstrated a 66 
percent drop in central line-associated bloodstream infection rates, 
saving 1,500 lives and $100 million. [Pronovost P, Needham D, 
Berenholtz S, Sinopoli D, Chu H, Cosgrove S, et al. An intervention to 
decrease catheter-related bloodstream infections in the ICU. N Engl J 
Med. 2006; 355(25):2725-32.] The study demonstrated that it was 
possible for a diverse array of hospitals with a diverse array of 
patients to adopt the same bundled set of best practices, apply them 
consistently and in a hospital-wide team-like fashion, and produce a 
massive reduction in CLABSIs over a sustained period. Importantly, the 
study also touched off a change in hospital culture, and weakened a 
long-held belief in the medical community that infections were 
inevitable, not truly preventable, and simply a cost of being a patient 
in a hospital. Since publication of this initial study, researchers 
have gone on to demonstrate how the reduction of CLABSIs also 
translates to reductions in mortality and in length of stay. [Lipitz-
Snyderman A, Steinwachs D, Needham D, Colantuoni E, Morlock L, 
Pronovost P, Impact of a statewide intensive care unit quality 
improvement initiative on hospital mortality and length of stay: 
retrospective comparative analysis. BMJ 2011; 342:d219.] Reductions 
have been demonstrated for other HAIs as well, but much more remains to 
be done.
    Finally, by requiring hospitals to adhere to ``nationally 
recognized guidelines,'' we aim to provide hospitals with a broad array 
of options and a large degree of flexibility. We recognize the 
potential for hospitals to become encumbered by competing initiatives 
and requirements whereby they are required to collect different data or 
implement varied solutions for the same problem. For this reason, we 
have drafted broad requirements to afford hospitals the flexibility to 
adopt the approaches which best fit their infection prevention and 
control needs.
Sec.  482.42(c)(2)(ii), (iii), (iv), (v), and (vi) The Infection 
Preventionists'/Infection Control Professionals' Responsibilities 
(Cont.)
    At Sec.  482.42(c)(2)(ii), we propose to make the infection 
preventionist(s)/infection control professional(s) responsible for all 
documentation, written or electronic, of the prevention and control 
program, and its surveillance, prevention, and control activities. As 
used in this context, the word ``documentation'' would encompass both 
collecting and maintaining pertinent information in a systematic 
fashion.
    At Sec.  482.42(c)(2)(iii), we would require that the infection 
preventionist(s)/infection control professional(s) communicate and 
collaborate with the hospital's QAPI program on all infection 
prevention and control issues. By the word ``issues'' we mean all 
concerns, including ones which are emerging and ones which are already 
problematic. We believe this approach will foster and enhance a 
proactive culture around hospitals' infection prevention and control 
programs.
    At Sec.  482.42(c)(2)(iv), we propose that the infection 
preventionist(s)/infection control professional(s) take a direct role 
in the competency-based training and education of hospital personnel 
and staff, including medical staff, and, as applicable, personnel 
providing contracted services in the hospital, on the practical 
applications of infection prevention and control guidelines, policies, 
and procedures. We believe that this proposed revision is more specific 
and more in keeping with current standards of practice in hospitals 
than the current provision at Sec.  482.42(b)(1) that requires a 
hospital to ensure that its training programs address problems 
identified by the infection control officer or officers.
    At Sec.  482.42(c)(2)(v), we propose that the infection 
preventionist(s)/infection control professional(s) be responsible for 
preventing and controlling HAIs, including auditing of adherence to 
infection prevention and control policies and procedures by hospital 
personnel. We believe the infection preventionist(s)/infection control 
professional(s) would find a comprehensive and timely resource in the 
HHS Action Plan to Prevent Healthcare-Associated Infections (HHS. ``HHS 
Action Plan to Prevent Healthcare-Associated Infections.'' Accessed 3 
August 2011 http://www.hhs.gov/ash/initiatives/hai/actionplan/index.html.).
    At Sec.  482.42(c)(2)(vi), we propose that the infection 
preventionist(s)/infection control professional(s) be responsible for 
communication and collaboration with the antibiotic stewardship 
program. Based on the evidence provided by CDC, IDSA, SHEA, and others, 
we believe that collaboration between the hospital's infection 
prevention and control and antibiotic stewardship programs will provide 
the optimal approach to reducing HAIs and antibiotic resistance.
Sec.  482.42(c)(3) The Antibiotic Stewardship Program Leader's 
Responsibilities
    Finally in this CoP, at Sec.  482.42(c)(3), we propose new 
requirements for the hospital's designated antibiotic stewardship 
program leader, similar to the responsibilities we have proposed for 
the hospital's designated infection preventionist(s)/infection control 
professional(s). Based on the evidence, we believe that a hospital 
antibiotic stewardship program is the most effective means for ensuring 
appropriate antibiotic use and for reducing HAIs and antibiotic 
resistance, including deadly CDI. We also believe that such a program 
would require a dedicated and expert leader responsible and accountable 
for its success. Therefore, those responsibilities would be:
     The development and implementation of a hospital-wide 
antibiotic stewardship program, based on nationally recognized 
guidelines, to monitor and improve the use of antibiotics;
     All documentation, written or electronic, of antibiotic 
stewardship program activities;
     Communication and collaboration with medical staff, 
nursing, and pharmacy leadership, as well as the hospital's infection 
prevention and control and QAPI programs, on antibiotic use issues; and
     The competency-based training and education of hospital 
personnel and staff, including medical staff, and, as applicable, 
personnel providing contracted services in the hospital, on the 
practical applications of antibiotic stewardship guidelines, policies, 
and procedures.

F. Technical Corrections

Technical Amendments to Sec.  482.27(b)(7)(ii) and (b)(11)
    In the final rule ``Medicare and Medicaid Programs; Hospital 
Conditions of Participation: Laboratory Services,'' amending 42 CFR 
482.27 (72 FR 48562, 48573, Aug. 24, 2007), we stated that HCV 
notification requirements for donors tested before February 20, 2008, 
would expire on August 24, 2015, in accordance with 21 CFR 610.48.
    Since the notification requirement period has expired, we propose 
to remove Sec.  482.27(b)(11), ``Applicability'' and the corresponding 
requirements set out at Sec.  482.27(b)(7)(ii).
Corrected Reference in Sec.  482.58
    In our review of the Hospital Conditions of Participation, we found 
an incorrect cross-reference at Sec.  482.58(b)(6), which currently 
reads

[[Page 39460]]

``Discharge planning (Sec.  483.20(e))''. Section 483.20(e) addresses 
coordination of the preadmission screening and resident review program, 
not discharge planning. SNF requirements for discharge plans are set 
out at Sec.  483.20(l). Therefore, we propose to correct the reference 
to read ``Discharge summary (Sec.  483.20(l))''.
Removal of Inappropriate References to Sec.  482.12(c)(1)
    Upon our review of the Hospital CoPs for this proposed rule, we 
discovered that there are several provisions that incorrectly reference 
Sec.  482.12(c)(1), which lists the types of physicians and applies 
only to patients who are Medicare beneficiaries. Section 482.12(c) 
states that the governing body of the hospital must ensure that every 
Medicare patient is under the care of one of the following 
practitioners:
     A doctor of medicine or osteopathy;
     A doctor of dental surgery or dental medicine who is 
legally authorized to practice dentistry by the State and who is acting 
within the scope of his or her license;
     A doctor of podiatric medicine, but only with respect to 
functions which he or she is legally authorized by the State to 
perform;
     A doctor of optometry who is legally authorized to 
practice optometry by the State in which he or she practices;
     A chiropractor who is licensed by the State or legally 
authorized to perform the services of a chiropractor, but only with 
respect to treatment by means of manual manipulation of the spine to 
correct a subluxation demonstrated by x-ray to exist; and
     A clinical psychologist as defined in Sec.  410.71, but 
only with respect to clinical psychologist services as defined in Sec.  
410.71 and only to the extent permitted by State law.
    The reference of this ``Medicare beneficiary-only'' requirement in 
other provisions of the CoPs inappropriately links it to all patients 
and not Medicare beneficiaries exclusively. In fact, the Act at section 
1861(e)(4) states that ``every patient with respect to whom payment may 
be made under this title must be under the care of a physician except 
that a patient receiving qualified psychologist services (as defined in 
subsection (ii)) may be under the care of a clinical psychologist with 
respect to such services to the extent permitted under State law.'' In 
accordance with that provision, we have chosen to apply Sec.  482.12(c) 
to Medicare patients. With the exception of a few provisions in the 
CoPs such as those directly related to Sec.  482.12(c) described here, 
the remainder of the CoPs apply to all patients, regardless of payment 
source, and not just Medicare beneficiaries. For example, the Nursing 
Services CoP, at Sec.  482.23(c)(1), requires that all drugs and 
biologicals must be prepared and administered in accordance with 
Federal and State laws, the orders of the practitioner or practitioners 
responsible for the patient's care as specified under Sec.  482.12(c), 
and accepted standards of practice. Since the CoPs clearly allow 
hospitals to determine which categories of practitioners would be 
responsible for the care of other patients, outside the narrow Medicare 
beneficiary restrictions of Sec.  482.12(c), this reference is 
inappropriate and unnecessarily restrictive of hospitals and their 
medical staffs to make these determinations based on State law and 
practitioner scope of practice.
    In order to clarify that these provisions apply to all patients and 
not only Medicare beneficiaries, in this rule we are proposing to 
delete any inappropriate references to Sec.  482.12(c). Therefore, we 
propose to delete references to Sec.  482.12(c) found in the following 
provisions: Sec.  482.13(e)(5), (e)(8)(ii), (e)(14), and (g)(4)(ii) in 
the Patients' Rights CoP; and Sec.  482.23(c)(1) and (3) in the Nursing 
Services CoP. With respect to all of these provisions, the reference to 
services provided under the order of a physician or other practitioner 
would still apply.

G. Critical Access Hospitals

    We have identified several priority areas in the CoPs for CAHs (42 
CFR part 485, subpart F) for updates and revisions. We believe that 
these proposed regulations would benefit the quality of care provided 
with a positive impact on patient satisfaction, length of stay, and, 
ultimately, cost per patient. Additionally, without potentially 
jeopardizing the quality of healthcare in rural areas, we have proposed 
the following changes to the CAH CoPs considering the resource 
restrictions of remote and frontier CAHs.
1. Organizational Structure (Sec.  485.627(b))
    The CoP at Sec.  485.627 provides that the CAH has a governing body 
or an individual that assumes full legal responsibility for 
determining, implementing and monitoring policies governing the CAH's 
total operation and for ensuring that those policies are administered 
so as to provide quality health care in a safe environment. The current 
standard at Sec.  485.627(b) requires the disclosure of names and 
addresses of the person(s) principally responsible for the operation 
and medical direction of the CAH in addition to the disclosure of 
individuals 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. Since the disclosure of persons having 
ownership, financial, or control interest is required via the provider 
enrollment process as discussed at Sec.  420.206, we do not believe 
that it is appropriate to repeat the requirement under the health and 
safety regulations. Therefore, we are proposing to delete the same 
disclosure requirement at Sec.  485.627(b)(1).
2. Periodic Review of Clinical Privileges and Performance (Sec.  
485.631(d)(1) Through (2))
    The current CoP at Sec.  485.641 requires a CAH to have an 
agreement with respect to credentialing and quality assurance with a 
hospital that is a member of the rural health network (when applicable) 
as defined in Sec.  485.603; one Quality Improvement Organization (QIO) 
or equivalent entity; or one other appropriate and qualified entity 
identified in the State rural health care plan to evaluate the quality 
and appropriateness of the diagnosis and treatment furnished by doctors 
of medicine (MDs) or osteopathy (DOs) at the CAH. In addition, the MD 
and DO (on staff or under contract with the CAH) must evaluate the 
quality and appropriateness of the diagnosis and treatment furnished by 
the CAH's non-physician practitioners.
    We are proposing to change the current CoP at Sec.  485.641 to 
reflect the current QAPI format used in hospitals. As such, we propose 
to retain the requirements under paragraphs Sec.  485.641(b)(3) through 
(4), that are currently found under the ``Periodic evaluation and 
quality assurance'' CoP, and relocate them under a new standard under 
the ``Staffing and staff responsibilities'' CoP at Sec.  485.631. We 
are not changing these requirements and believe that they are still 
appropriate for the CAH regulations. Since the current CoP under Sec.  
485.631 discusses staffing requirements and responsibilities, we 
believe that relocating the requirement under a new standard, entitled 
``Periodic Review of Clinical Privileges and Performance'' (Sec.  
485.631(d)) is a more appropriate placement for the current provisions 
requiring a CAH to evaluate the quality of care provided by their nurse 
practitioners, clinical nurse specialists, certified nurse midwives, 
physician assistants, doctors of medicine, or doctors of osteopathy.

[[Page 39461]]

3. Provision of Services (Sec.  485.635(a)(3)(vii))
    We currently require CAHs at Sec.  485.635(a)(3)(vii) to have 
procedures that ensure that the nutritional needs of inpatients are met 
in accordance with recognized dietary practices and the orders of the 
practitioner responsible for the care of the patients and that the 
requirement of Sec.  483.25(i) is met with respect to inpatients 
receiving post-hospital SNF care. This current requirement asserts that 
a therapeutic diet must be prescribed only by the practitioner or 
practitioners responsible for the care of the patient.
    We finalized a change in the May 12, 2014 Federal Register (79 FR 
27106) to the hospital requirement for Food and Dietetic services 
(Sec.  482.28) that all patient diets, including therapeutic diets, 
must be ordered by a practitioner responsible for the care of the 
patient, or by a qualified dietician or qualified nutrition 
professional as authorized by the medical staff and in accordance with 
State law governing dietitians and nutrition professionals. We are 
proposing a similar change for CAHs because we believe that these rural 
providers and beneficiaries would benefit from such a change. The 
responsibility for the care of the patient in a CAH has traditionally 
been the responsibility of the physician, more specifically the MD and 
DO, and the APRN and PA. We believe that a team-based approach that 
allows for professionals to practice in their area of expertise and to 
the fullest extent allowed by state law would be of great benefit to 
CAH patients. We further believe that patients in these traditionally 
underserved areas deserve the same standard of care as patients receive 
in better-served areas.
    Based on feedback from the provider community, we have come to the 
conclusion that the regulatory language is too restrictive and lacks 
the reasonable flexibility to allow CAHs to permit registered 
dieticians (RDs) to order therapeutic diets for patients in accordance 
with State laws. Because some States elect not to use the regulatory 
term ``registered'' and choose instead to use the term ``licensed'' (or 
no modifying term at all), or because some States also recognize other 
nutrition professionals with equal or possibly more extensive 
qualifications, we propose to use the term ``qualified dietitian.'' In 
those instances where we have used the most common abbreviation for 
dietitians, ``RD,'' in this preamble, our intention is to include all 
qualified dietitians and any other clinically qualified nutrition 
professionals, regardless of the modifying term (or lack thereof), as 
long as each qualified dietitian or qualified nutrition professional 
meets the requirements of his or her respective State laws, 
regulations, or other appropriate professional standards.
    Based on a review of the professional literature on this subject, 
we believe that RDs are the professionals who are best qualified to 
assess a patient's nutritional status and to design and implement a 
nutritional treatment plan in consultation with the patient's 
interdisciplinary care team. In order for patients to receive timely 
nutritional care, the RD must be viewed as an integral member of the 
CAH's interdisciplinary care team, one who, as the team's clinical 
nutrition expert, is responsible for a patient's nutritional diagnosis 
and treatment in light of the patient's medical diagnoses. Without the 
proposed regulatory changes allowing them to grant appropriate ordering 
privileges to RDs, CAHs would not be able to effectively realize the 
improved patient outcomes and overall cost savings that we believe 
would be possible with such changes. The literature also supports the 
conclusion that, in addition to providing safe patient care with 
improved outcomes, RDs with ordering privileges contribute to decreased 
patient lengths of stay and provide nutrition services more 
efficiently, resulting in lower costs for hospitals, including small 
and rural hospitals as well as CAHs. (Kinn TJ. Clinical order writing 
privileges. Support Line. 2011; 33; 4; 3-10). A 2010 retrospective 
cohort study of 1,965 patients at an academic medical center looked at 
the influence of the RD with ordering privileges on appropriate 
parenteral nutrition (PN) usage (Peterson SJ, Chen Y, Sullivan CA, et 
al. Assessing the influence of registered dietician order-writing 
privileges on parenteral nutrition use. J AM Diet Assoc. 2010; 110; 
1702 1711). The study showed that inappropriate PN usage decreased from 
482 patients to 240 patients during the pre- and post-ordering 
privileges periods, respectively. The data from this study also 
demonstrated a 20 percent cost savings in PN usage. Additionally, this 
proposed change might also help CAHs to realize other significant 
quality and patient safety improvements as well as savings. A 2008 
study indicates that patients whose PN regimens were ordered by RDs 
have significantly fewer days of hyperglycemia (57 percent versus 23 
percent) and electrolyte abnormalities (72 percent versus 39 percent) 
compared with patients whose PN regimens were ordered by physicians 
(Duffy JK, Gray RL, Roberts S, Glanzer SR, Longoria SL. Independent 
nutrition order writing by registered dieticians reduces complications 
associated with nutrition support [abstract]. J Am Diet Assoc. 2008; 
108 (suppl 1):A9).
    Physicians, APRNs, and PAs might lack the training and educational 
background to manage the sometimes complex nutritional needs of 
patients with the same degree of efficiency and skill as RDs who have 
benefited from curriculums that devote a significant number of 
educational hours to this area of medicine. The addition of ordering 
privileges enhances the ability that RDs already have to provide 
timely, cost-effective, and evidence-based nutrition services as the 
recognized nutrition experts on a hospital and a CAH interdisciplinary 
team and saves valuable time in the care and treatment of patients, 
time that is now often wasted as RDs must seek out physicians, APRNs, 
and PAs to write or co-sign dietary orders. A 2011 literature review 
discusses a number of additional studies that provide further evidence 
for the extensive training and education in nutrition that RDs 
experience as opposed to the limited exposure that physicians receive 
to this area of medicine, along with several other studies supporting 
the cost-effectiveness and positive patient outcomes that hospitals 
might achieve by granting RDs ordering privileges (Kinn TJ. Clinical 
order writing privileges. Support Line. 2011; 33; 4; 3-10).
    In order for patients to have access to the timely nutritional care 
that can be provided by RDs, especially in rural and remote areas, a 
CAH must have the regulatory flexibility either to appoint RDs to the 
medical staff and grant them specific nutritional ordering privileges 
or to authorize the ordering privileges without appointment to the 
medical staff. In either instance, medical staff oversight of RDs and 
their ordering privileges would be ensured. Therefore, we are proposing 
revisions to Sec.  485.635(a)(3)(vii) that would require that 
individual patient nutritional needs be met in accordance with 
recognized dietary practices and the orders of the practitioner 
responsible for the care of the patients, or by a qualified dietician 
or qualified nutrition professional as authorized by the medical staff 
in accordance with State law governing dietitians and nutrition 
professionals. In addition, we are also proposing that the requirement 
of Sec.  483.25(i) is met with respect to inpatients receiving post 
hospital SNF care. Evidence shows that if CAHs choose to grant these 
specific

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ordering privileges to RDs they might achieve a higher quality of care 
for their patients by allowing these professionals to fully and 
efficiently function as important members of the patient care team in 
the role for which they were trained. As a result, it is expected that 
CAHs would realize cost savings in many of the areas affected by 
nutritional care. We welcome public comments on this proposed change.
Provision of Services (Sec.  485.635(g))
    At Sec.  485.635(g) we propose a new requirement regarding non-
discriminatory behavior. As discussed in this preamble at Sec.  482.13 
with regard to hospitals, we are aware that discriminatory behavior by 
healthcare providers can create barriers to care and result in adverse 
outcomes for patients. The fear of discrimination alone can limit the 
extent to which a person accesses health services.
    While the CAH CoPs at Sec.  485.608 require that a CAH be in 
compliance with applicable Federal laws related to the health and 
safety of patients, there is currently no explicit prohibition of 
discrimination in the CAH CoPs. We propose to require that a CAH not 
discriminate on the basis of race, color, religion, national origin, 
sex (including gender identity), sexual orientation, age, or 
disability. We are proposing these requirements to ensure 
nondiscrimination as required by Section 1557 of the Affordable Care 
Act, which prohibits health programs and activities that receive 
federal financial assistance, such as Medicare and Medicaid, from 
excluding or denying beneficiaries participation based on their race, 
color, national origin, sex (including gender identity), age, or 
disability. As discussed in section II.A.1 of this proposed rule, we 
believe that discrimination based on a patient's religion or sexual 
orientation can potentially lead to a denial of services or inadequate 
care, which is detrimental to the patient's health and safety. We are 
therefore also proposing to establish explicit requirements that a CAH 
not discriminate on the basis of religion or sexual orientation and 
that a CAH establish and implement a written policy prohibiting 
discrimination on the basis of religion or sexual orientation. We are 
doing so under the statutory authority of Section 1820(e)(3) of the 
Act, which sets forth the conditions for designating certain hospitals 
as CAHs.
    We further propose that CAHs establish and implement a written 
policy prohibiting discrimination. As noted in our explanation of the 
proposed policy applicable to hospitals, freedom from discrimination 
correlates with improved health outcomes. The same would be true of 
CAHs.
    CAHs would be required to inform each patient (including the 
patient's support person, where appropriate) of the right to be free 
from discrimination in a language that the patient can understand. In 
addition, we propose to require that the CAH inform the patient and/or 
representative, and/or support person, on how he or she can seek 
assistance if they encounter discrimination.
4. Infection Prevention and Control and Antibiotic Stewardship Programs 
(Sec.  485.640)
    CMS retained the former Essential Access Community Hospitals and 
Rural Primary Care Hospitals (EACH/RPCH) Infection Control regulation 
for CAHs in the 1997 Federal Register (62 FR 46008, August 29, 1997) in 
the subsequent CoP requirements at Sec.  485.635(a)(3)(vi) and at Sec.  
485.641(b)(2). The infection control requirements for CAHs have 
remained unchanged since 1997. We are proposing to remove the current 
requirements at Sec. Sec.  485.635(a)(3)(vi) and 485.641(b)(2) and are 
adding a new infection prevention and control and antibiotic 
stewardship CoP for CAHs because the existing standards for infection 
control do not reflect the current nationally recognized standards of 
practice for the prevention and elimination of healthcare-associated 
infections and for the appropriate use of antibiotics.
    We discuss at length in this preamble at Sec.  482.42 the issues 
and concerns regarding infection control, healthcare-associated 
infections, antibiotic overuse, and the industry recommendations for 
addressing these serious and growing problems. Therefore, we will not 
have a lengthy discussion of the background and rationale in this 
section. Additionally, note that a March 6, 2014 article of the Health 
Leaders Media entitled, ``Size Matters in Antibiotic Overuse,'' 
discusses the variation in prescribing practices among hospitals 
(Cheryl Clark, Health Leaders Media Council Quality e-Newsletter, March 
6, 2014). Some hospitals are prone to give antibiotics as much as three 
times more often than other hospitals, despite a similar patient mix. 
The article features research results authored by clinicians at a large 
hospital system with more than 80 hospitals in 21 states. The research 
showed that antibiotic prescribing practices at 69 hospitals had 
significant variations in the use of antibiotics across the 69 
hospitals. They found that the lower the ``case mix index,'' or 
severity of illness at a particular hospital, and the smaller the 
hospital in terms of number of beds, the more antibiotics were used on 
patients and the more money was spent on the cost of those drugs. The 
report discussed that one possible cause could be that hospitals 
located in smaller, perhaps rural areas, or CAHs might lack access to 
rapid, sophisticated lab equipment to identify the type of microbes 
their patients might have.
    The report also theorized that it was likely that smaller hospitals 
do not have as robust of an antimicrobial stewardship program as larger 
hospitals. The research documented several factors associated with 
higher antibiotic use at smaller or rural hospitals:
     Lack of awareness on judicious antibiotic use;
     Lack of teamwork among pharmacists and physicians;
     Lack of a formal process on appropriate indications for 
broad spectrum agent use;
     Lack of prospective monitoring on continuation of broad 
spectrum agent use, such as de-escalation of use after negative result 
from culture and sensitivity testing; and
     Lack of resistance trend monitoring and making appropriate 
process changes to reduce resistance.
    We are therefore proposing that each CAH has facility-wide 
infection prevention and control and antibiotic stewardship programs. 
The programs would be coordinated with the CAH QAPI program, for the 
surveillance, prevention, and control of HAIs and other infectious 
diseases and for the optimization of antibiotic use through 
stewardship. We are emphasizing the importance of antibiotic 
stewardship because it could play a vital role in a CAH's successful 
efforts in combatting antimicrobial resistance. The programs would 
demonstrate adherence to nationally recognized infection control 
guidelines, where applicable, for reducing the transmission of 
infections, as well as best practices for improving antibiotic use and 
reducing the development and transmission of HAIs and antibiotic-
resistant organisms. We believe that this approach would provide CAHs 
the flexibility they need to select and integrate standards and best 
practices which are best suited to their individual infection 
prevention and control program.
Sec.  485.640(a)(1) and (2) Infection Control Officer(s); and 
Prevention and Control of Infections Within the CAH and Between the CAH 
and Other Healthcare Settings
    At Sec.  485.640(a)(1) we propose that the CAH ensure that an 
individual (or individuals), who are qualified through

[[Page 39463]]

education, training, experience, or certified in infection, prevention 
and control, are appointed by the governing body, or responsible 
individual, as the infection preventionist(s)/infection control 
professional(s) responsible for the infection prevention and control 
program at the CAH and that the appointment is based on the 
recommendations of medical staff and nursing leadership. We recognize 
that CAHs use a variety of staffing models including direct employment, 
contracted services, and shared service agreements. In Sec.  485.640, 
we do not require any specific staffing model(s) for the 
professional(s) responsible for the facility-wide infection prevention 
and control and antibiotic stewardship programs. The CAH's staffing for 
these programs should be appropriate to the scope and complexity of the 
services offered at the CAH.
    We propose at Sec.  485.640(a)(2) that the infection prevention and 
control program, as documented in its policies and procedures, employ 
methods for preventing and controlling the transmission of infections 
within the CAH and between the CAH and other healthcare settings. We 
believe that a coordinated, overall quality approach would enable CAHs 
to achieve results that would better serve their patients and reduce 
cost. The program, as documented in its policies and procedures, would 
have to employ methods for preventing and controlling the transmission 
of infection within the CAH setting (for example, among patients, 
personnel, and visitors) as well as between the CAH (including 
outpatient services) and other institutions and healthcare settings. As 
discussed at section II.G of this preamble, we would expect CAHs to 
look to the CDC guidelines for guidance (http://www.cdc.gov/hai/pdfs/guidelines/Ambulatory-Care+Checklist_508_11_2015.pdf.)
Sec.  485.640(a)(3) Healthcare-Associated Infections (HAIs)
    We propose at Sec.  485.640(a)(3) that the infection prevention and 
control program include surveillance, prevention, and control of HAIs, 
including maintaining a clean and sanitary environment to avoid sources 
and transmission of infection, and that the program also address any 
infection control issues identified by public health authorities.
Sec.  485.640(a)(4) Scope and Complexity
    We are proposing at Sec.  485.640(a)(4) that the infection 
prevention and control program reflects the scope and complexity of the 
services provided by the CAH.
Sec.  485.640(b)(1) Leader of the Antibiotic Stewardship Program
    We propose at Sec.  485.640(b)(1) that the CAH's governing body 
ensure that an individual, who is qualified through education, 
training, or experience in infectious diseases and/or antibiotic 
stewardship is appointed as the leader of the antibiotic stewardship 
program and that the appointment is based on the recommendations of 
medical staff and pharmacy leadership.
Sec.  485.640(b)(2)(i),(ii), and (iii) Goals of the Antibiotic 
Stewardship Program
    The proposed requirements at Sec.  485.640(b)(2)(i),(ii), and (iii) 
would ensure that the following goals for an antibiotic stewardship 
program are met: (i) Demonstrate coordination among all components of 
the CAH responsible for antibiotic use and resistance, including, but 
not limited to, the infection prevention and control program, the QAPI 
program, the medical staff, and nursing and pharmacy services; (ii) 
document the evidence-based use of antibiotics in all departments and 
services of the CAH; and (iii) demonstrate improvements, including 
sustained improvements, in proper antibiotic use, such as through 
reductions in, CDI and antibiotic resistance in all departments and 
services of the hospital. We believe that these three components are 
essential for an effective program.
Sec.  485.640(b)(3) and (4) Nationally Recognized Guidelines; and Scope 
and Complexity
    These provisions would require the CAH to ensure that the 
antibiotic stewardship program adheres to the nationally recognized 
guidelines, as well as best practices, for improving antibiotic use. 
The CAH's stewardship program would have to reflect the scope and 
complexity of services offered. For example, we would not expect a CAH 
that did not offer surgical services to address antibiotic stewardship 
issues specific to surgical patients. We believe these proposed 
requirements are necessary to promote a facility-wide culture of 
quality improvement.
Sec.  485.640(c)(1), (2), and (3) Governing Body; Infection Prevention 
and Control Professionals'; and Antibiotic Stewardship Program Leader's 
Responsibilities
    We would require that the governing body or responsible individual 
ensure that the infection prevention and control issues identified by 
the infection prevention and control professionals be addressed in 
collaboration with CAH leadership. We therefore propose at Sec.  
485.640(c)(1)(i) and (ii), requirements that the governing body or 
responsible individual ensure that:
     Systems are in place and operational for the tracking of 
all infection surveillance, prevention, and control, and antibiotic use 
activities in order to demonstrate the implementation, success, and 
sustainability of such activities; and
     All HAIs and other infectious diseases identified by the 
infection prevention and control program and antibiotic use issues 
identified by the antibiotic stewardship program are addressed in 
collaboration with CAH QAPI leadership.
    At Sec.  485.640(c)(2)(i)-(vi), we propose that the 
responsibilities of the infection prevention and control professionals 
would include the development and implementation of facility-wide 
infection surveillance, prevention, and control policies and procedures 
that adhere to nationally recognized guidelines.
    The governing body or responsible individual would be responsible 
for all documentation, written or electronic, of the infection 
prevention and control program and its surveillance, prevention, and 
control activities. Additionally, the infection preventionist(s)/
infection control professional(s) would be responsible for:
     Communication and collaboration with the CAH's QAPI 
program on infection prevention and control issues;
     Competency-based training and education of CAH personnel 
and staff including professional health care staff and, as applicable, 
personnel providing services in the CAH under agreement or arrangement, 
on the practical applications of infection prevention and control 
guidelines, policies and procedures;
     Prevention and control of HAIs, including auditing of 
adherence to infection prevention and control policies and procedures 
by CAH personnel; and
     Communication and collaboration with the antibiotic 
stewardship program.
    Finally in this CoP, at Sec.  485.640(c)(3), we propose 
requirements for the leader of the antibiotic stewardship program 
similar to the proposed responsibilities for the CAH's designated 
infection preventionist(s)/infection control professional(s) at 
paragraph (c)(2). We believe that a CAH's antibiotic stewardship 
program is the most effective means for ensuring appropriate antibiotic 
use. We also believe that such

[[Page 39464]]

a program would require a leader responsible and accountable for its 
success. Therefore, we propose that the leader of the antibiotic 
stewardship program would be responsible for the development and 
implementation of a facility-wide antibiotic stewardship program, based 
on nationally recognized guidelines, to monitor and improve the use of 
antibiotics. We also propose that the leader of the antibiotic 
stewardship program would be responsible for all documentation, written 
or electronic, of antibiotic stewardship program activities. The leader 
would also be responsible for communicating and collaborating with 
medical and nursing staff, pharmacy leadership, and the CAH's infection 
prevention and control and QAPI programs, on antibiotic use issues.
    Finally, we propose that the leader would be responsible for the 
competency-based training and education of CAH personnel and staff, 
including medical staff, and, as applicable, personnel providing 
contracted services in the CAHs, on the practical applications of 
antibiotic stewardship guidelines, policies, and procedures.
5. Quality Assessment and Performance Improvement (QAPI) Program (Sec.  
485.641)
    Since May 26, 1993 (58 FR 30630), the ``Periodic evaluation and 
quality assurance review'' CoP (Sec.  485.641) has not been updated to 
reflect current industry standards that utilize the QAPI model (Sec.  
482.21) to assess and improve patient care. Currently, a CAH is 
required to evaluate its total program (for example, policies and 
procedures and services provided) annually. The evaluation must include 
reviewing the utilization of the CAH services using a representative 
sample of both active and closed clinical records, as well as reviewing 
the facility's health care policies. The purpose of the evaluation is 
to determine whether the utilization of services was appropriate, the 
established policies were followed, and if any changes are needed. The 
CAH's staff considers the findings of the evaluation and takes the 
necessary corrective action. These requirements focus on how well the 
CAH adhered to the evaluation standards and require the CAH to document 
its efforts. The existing annual evaluation and quality assurance 
review requirements at Sec.  485.641 are reactive; that is, once a 
problem has been identified, the health care facility takes action to 
correct it.
    The focus of a QAPI program is to proactively maximize quality 
improvement activities and programs, even in areas where no specific 
deficiencies are noted. A QAPI program enables the organization to 
review systematically its operating systems and processes of care to 
identify and implement opportunities for improvement.
    An effective QAPI program that is engaged in continuous improvement 
efforts is essential to a provider's ability to provide high quality 
and safe care to its patients, while reducing the incidence of medical 
errors and adverse events. However, patient harm still remains a 
considerable problem in our nation's hospitals. The IOM report, ``To 
Err Is Human: Building a Safer Health System,'' focused widespread 
attention on the problem of adverse events and is a call to action for 
the entire health care system. (L.T. Kohn, J.M. Corrigan, and M.S. 
Donaldson, eds., To Err Is Human: Building a Safer Health System, A 
Report of the Committee on Quality of Health Care in America, p. 102, 
IOM, National Academy Press, 2000.) The report highlighted patient 
injuries associated with medical errors. More recent reports, however, 
document that the problems identified in ``To Err is Human'' have not 
yet been resolved. A 2010 Office of the Inspector General Report 
estimated that during October 2008, 13.5 percent of hospitalized 
Medicare beneficiaries experienced adverse events during their hospital 
stays (Department of Health and Human Services Office of Inspector 
General, ``Adverse Events in Hospitals: National Incidence Among 
Medicare Beneficiaries'' (OEI-06-09-00090). A 2013 literature review 
concluded that at least 210,000 deaths per year were associated with 
preventable harm in hospitals. The evidence indicates that patients are 
being harmed every day in hospitals across the country and that more 
work is needed to reduce this harm.
    In ``To Err is Human,'' an error is defined as ``the failure of a 
planned action to be completed as intended or the use of a wrong plan 
to achieve an aim.'' Examples of medical errors include:
     Medication administration errors (for example, wrong 
medication, wrong dosage, wrong route, wrong time, wrong patient.);
     Equipment failures (for example, defibrillator without 
working batteries, etc.); and
     Diagnostic errors.
    A 2003 report by The National Advisory Committee on Rural Health 
and Human Services to the Secretary of the HHS notes that the general 
concept of health care quality does not change from urban to rural 
settings (The National Advisory Committee on Rural Health and Human 
Services. Health Care Quality: The Rural Context. April, 2003; p. 6-
10). The focus remains on providing the right service at the right time 
in the right way to achieve the optimal outcome. The only rural-urban 
variable within that equation is the context. While the notion of 
quality remains constant, the settings in which the care is provided--
including their structures and processes (for example, transferring 
patients to larger facilities vs. being able to keep them for 
observation)--can be quite different. The most elementary differences 
have to do with scope and scale.
    The 2004 IOM Report, ``Quality Through Collaboration: The Future of 
Rural Health,'' reports that to improve quality, rural providers, like 
their urban counterparts, must adopt a comprehensive approach to 
quality improvement (National Research Council. Quality Through 
Collaboration: The Future of Rural Health Care. Washington, DC: The 
National Academies Press, 2005. http://www.iom.edu/Reports/2004/Quality-Through-Collaboration-The-Future-of-Rural-Health.aspx#sthash.2zF6T8kE.dpuf dpuf). This approach needs to encompass 
clinical knowledge and the tools necessary to apply this knowledge to 
practice, including practice guidelines and computer-aided decision 
support, standardized performance measures, performance measurement and 
data feedback capabilities, and quality improvement processes and 
resources.
    A QAPI program would enable a CAH to systematically review its 
operating systems and processes of care to identify and implement 
opportunities for improvement. We also believe that the leadership or 
governing body or responsible individual of a CAH must be responsible 
and accountable for patient safety, including the reduction of medical 
errors in the facility.
    We propose to revise Sec.  485.641 to set forth new explicit 
requirements for a QAPI program at a CAH. We believe that much of the 
work and resources that are currently required under the existing 
periodic evaluation and quality assurance CoP would be utilized to 
adhere to the new QAPI requirement. As noted previously, we propose to 
retain the requirements under paragraphs Sec.  485.641(b)(3) and (4) 
regarding the evaluation of the diagnosis and treatment furnished by 
physicians and non-physician practitioners; we are proposing that this 
be moved from the ``Periodic evaluation and quality assurance'' CoP, 
and relocate them to a

[[Page 39465]]

new standard under the ``Staffing and staff responsibilities'' CoP at 
Sec.  485.631.
    CAHs are currently required to have an effective quality assurance 
program to evaluate the quality and appropriateness of the diagnosis 
and treatment furnished in the CAH and of the treatment outcomes. We 
are proposing that, under Sec.  485.641, the CAH be required to 
develop, implement, and maintain an effective, ongoing, facility-wide, 
and data-driven QAPI program. The QAPI program would have to be 
appropriate for the complexity of the CAH's organization and services 
provided.
    We propose to rename the current ``Periodic evaluation and quality 
assurance review'' provisions at Sec.  485.641 ``Condition of 
participation: Quality assessment and performance improvement 
program.'' At Sec.  485.641, we also propose to revise and replace the 
current standards with the new proposed QAPI program containing the 
following six parts: (a) Definitions; (b) QAPI program design and 
scope; (c) Governance and leadership; (d) Program activities; (e) 
Performance improvement projects; and (f) Program data collection and 
analysis.
Sec.  485.641(a) Definitions
    We have proposed at paragraph Sec.  485.641(a) to provide 
definitions for the following terms: ``adverse event,'' ``error,'' and 
``medical error.'' We propose the same definition of ``adverse event'' 
currently found at Sec.  482.70. We are also proposing the definitions 
of ``error'' and ``medical error'' that are largely drawn from the IOM. 
We believe that most CAHs are aware of these terms, but we are 
proposing to provide the following standard definitions:
     ``Adverse event'' means an untoward, undesirable, and 
usually unanticipated event that causes death or serious injury or the 
risk thereof;
     ``Error'' means the failure of a planned action to be 
completed as intended or the use of a wrong plan to achieve an aim. 
Errors can include problems in practice, products, procedures, and 
systems; and
     ``Medical error'' means an error that occurs in the 
delivery of healthcare services.
Sec.  485.641(b) QAPI Program Design and Scope
    At proposed Sec.  485.641(b)(1) ``Program design and scope,'' we 
would require the CAH to have a QAPI program that would be appropriate 
for the complexity of the CAH's organization and services. This means 
that every CAH would utilize performance improvement measures that 
would be sensitive to that CAH's specific context. The QAPI program 
would be designed to monitor and evaluate performance of all services 
and programs of the CAH. In proposed paragraphs (b)(2) and (3), we 
would require the CAH to design a QAPI program that would be on-going 
and comprehensive, involving all departments of the CAH and services, 
including those services furnished under contract or arrangement. In 
proposed paragraph (b)(4), we would require CAHs to use objective 
measures in their QAPI program to evaluate its organizational 
processes, functions, and services. We also propose at paragraph (b)(5) 
that the CAH's QAPI program would address outcome indicators related to 
improved health outcomes and the prevention and reduction of medical 
errors, adverse events, hospital-acquired conditions, and transitions 
of care, including readmissions.
Sec.  485.641(c) Governance and Leadership
    We propose at Sec.  485.641(c) that the CAH's governing body or 
responsible individual be ultimately responsible for the CAH's QAPI 
program and at paragraph (c)(1) be responsible and accountable for 
ensuring that clear expectations for safety are communicated, 
implemented, and followed throughout the CAH. At Sec.  485.641(c)(2), 
we propose that the QAPI efforts address priorities for improving 
quality of care and patient safety. At paragraph (c)(3), all 
improvement actions would be evaluated and modified as needed by the 
designated CAH staff. We propose at paragraph (c)(4) that the governing 
body or responsible individual exercising management authority over the 
CAH ensure that adequate resources are allocated for measuring, 
assessing, improving, and sustaining the CAH's performance and reducing 
risk to patients. Once this rule is finalized, CMS will develop the 
appropriate subregulatory guidance so that surveyors will be able to 
determine what constitutes ``adequate resources.'' In proposed 
paragraphs (c)(5) and (6), we would require the governing body or 
responsible individual to be responsible for annually determining the 
number of distinct quality improvement projects the CAH would conduct. 
They would also be responsible for the CAH developing and implementing 
policies and procedures for QAPI that address what actions the CAH 
staff should take to prevent and report unsafe patient care practices, 
medical errors, and adverse events.
485.641(d) Program Activities
    We propose at Sec.  485.641(d), ``Program activities'', that for 
each of the areas discussed in paragraphs (b) and (c) of this section, 
the CAH would have to:
     Focus on measures related to improved health outcomes that 
are shown to be predictive of desired patient outcomes;
     Use the measures to analyze and track its performance; and
     Set priorities for performance improvement, considering 
either high-volume, high-risk services, or problem-prone areas.
    Analyses would be expected to be conducted at regular intervals to 
enable the CAH to identify areas or opportunities for improvement.
Sec.  485.641(e) Performance Improvement Projects
    We propose at Sec.  485.641(e), ``Performance Improvement 
Projects,'' that a CAH would have to conduct distinct performance 
improvement projects that are proportional to the scope and complexity 
of the CAH's services and operations. We also propose that the CAH 
would be required to maintain and demonstrate written or electronic 
evidence and documentation of its QAPI projects.
Sec.  485.641(f) Program Data Collection and Analysis
    Collecting and analyzing data is fundamental to quality 
improvement. The CAH should be able to demonstrate that the data it 
collects measure the quality of patient care. Therefore, we propose at 
Sec.  485.641(f)(1) and (2) that a CAH's QAPI program be required to 
incorporate quality indicator data including patient care data, quality 
measures data, and other relevant data. The CAH must use the data 
collected to monitor the effectiveness and safety of services provided 
and quality of care. A CAH must also identify opportunities for 
improvement and changes that will lead to improvement. Since 2011, the 
Medicare Beneficiary Quality Improvement Project (MBQIP), supported by 
the Federal Office of Rural Health Policy's Medicare Rural Hospital 
Flexibility Grant Program, has encouraged CAHs to collect and report 
quality data and has provided a means for CAHs to monitor the quality 
of care they provide and identify opportunities for improvement. To the 
extent that the MBQIP meets the proposed requirements for incorporating 
quality indicator data in its QAPI program, CAH adherence to the 
requirements of MBQIP is one such way that the CAH's QAPI program data 
collection

[[Page 39466]]

requirements can be satisfied. MBQIP uses a rural-relevant subset of 
data based on Medicare quality reporting program. Current MBQIP 
measures and information resources for data analysis and performance 
improvement can be found at https://www.ruralcenter.org/tasc/mbqip. We 
propose at paragraph (f)(3) that the CAH's governing body or 
responsible individual must approve the frequency and the details of 
data collection.
6. Technical Corrections
    We propose to correct a typographical error in the regulations at 
Sec.  485.645 by correcting the word ``provided'' to ``provide'' in the 
lead first sentence.

III. Collection of Information Requirements

    Under the Paperwork Reduction Act of 1995, 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 Paperwork Reduction Act 
of 1995 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 these issues for the 
following sections of this document that contain information collection 
requirements (ICRs).

A. ICRs Regarding Patient's Rights (Sec.  482.13)

    Proposed Sec.  482.13(i) would establish explicit requirements that 
a hospital not discriminate against a patient or applicant for services 
on the basis of race, color, religion, national origin, sex (including 
gender identity), sexual orientation, or disability and that the 
hospital establish and implement a written policy prohibiting 
discrimination against a patient or applicant for services on the basis 
of race, color, religion, national origin, sex (including gender 
identity), sexual orientation, or disability. We propose to further 
require that each patient or applicant for services, and/or support 
person, where appropriate, is informed of the right to be free from 
discrimination against them on any of the aforementioned bases when he 
or she is informed of his or her other rights under Sec.  482.13(a)(1). 
The burden associated with this requirement is the time and effort 
necessary for a hospital to develop written policies and procedures 
with respect to the rights of patients to be free from discrimination 
and to distribute that information to the patients.
    We believe that most hospitals already have established policies 
and procedures regarding the rights of patients to be free from 
discrimination. Additionally, we believe that most hospitals include 
the anti-discrimination policies and procedures as part of their 
standard notice of patient rights. The burden associated with the 
notice of patient rights is currently approved under OMB control number 
0938-0328.
    We will be submitting a revision of the currently approved 
information collection request to account for the following burden.
    We estimate that 4,900 hospitals must comply with the 
aforementioned information collection requirements. We further estimate 
that it will take each hospital 0.25 hours to comply with the 
requirement in proposed Sec.  482.13(i). The total estimated annual 
burden associated with this requirement is 1,225 hours (4,900 hospitals 
x .25) at a cost of $83,300 (1,225 hours x $68 for a nurse's hourly 
salary).

B. ICRs Regarding Quality Assessment and Performance Improvement (Sec.  
482.21)

    The existing QAPI CoP requires each hospital to:
     Develop, implement, maintain, and evaluate its' own QAPI 
program;
     Establish a QAPI program that reflects the complexity of 
its organization and services;
     Establish a QAPI program that involves all hospital 
departments and services and focuses on improving health outcomes and 
preventing and reducing medical errors; and
     Maintain and demonstrate evidence of its QAPI program for 
review by CMS.
    We are proposing a minor change to the program data requirements at 
Sec.  482.21(b). Currently, we require that hospitals incorporate 
quality indicator data including patient care data, and other relevant 
data, for example, information submitted to, or received from, the 
hospital's Quality Improvement Organization.
    We propose to update this requirement to reflect and capitalize on 
the wealth of important quality data available to hospitals through 
several quality data reporting programs. Specifically, we propose to 
require that the hospital QAPI program must incorporate quality 
indicator data including patient care data, and other relevant data 
such as data submitted to or received from quality reporting and 
quality performance programs, including, but not limited to, data 
related to hospital readmissions and hospital-acquired conditions. 
Hospitals are likely to be participating in one or more existing 
quality reporting and quality performance programs such as the Hospital 
Inpatient Quality Reporting program, the Hospital Value-Based 
Purchasing Program, the Hospital Acquired Condition Reduction program, 
Hospital Compare, the Medicare and Medicaid Electronic Health Record 
Incentive Programs, the Hospital Outpatient Quality Reporting program, 
and the Joint Commission's Quality CheckTM. Since a hospital 
is already collecting and reporting quality measures data for these 
programs, we do not believe that this proposed change would increase 
the information collection burden for hospitals.

C. ICRs Regarding Nursing Services (Sec.  482.23)

    We propose to revise Sec.  482.23(b), which currently states 
``There must be supervisory and staff personnel for each department or 
nursing unit to ensure, when needed, the immediate availability of a 
registered nurse for bedside care of any patient,'' to delete the term 
``bedside,'' which might imply only inpatient services to some readers. 
The nursing service must ensure that patient needs are met by ongoing 
assessments of patients' needs and must provide nursing staff to meet 
those needs regardless of whether the patient is an inpatient or an 
outpatient. We propose to allow a hospital to establish a policy that 
would specify which, if any, outpatient units would not be required to 
have an RN physically present as well as the alternative staffing plans 
that would be established under such a policy. We would require such a 
policy to take into account factors such as the services delivered; the 
acuity of patients typically served by the facility; and the 
established standards of practice for such services. In addition, we 
would propose that the policy must be approved by the medical staff and 
be reviewed annually. TJC-accredited hospitals are already allowed this 
flexibility in nursing services policy. Those hospitals that use their 
TJC accreditation for deeming purposes are required to have ``Leaders 
[who] provide

[[Page 39467]]

for a sufficient number and mix of individuals to support safe, quality 
care, treatment, and services. (Note: The number and mix of individuals 
is appropriate to the scope and complexity of the services offered.)'' 
(CAMH, Standard LD.03.06.01, EP 3). Further, TJC-accredited hospitals 
also require the ``nurse executive, registered nurses, and other 
designated nursing staff [to] write: Nursing policies and procedures.'' 
(CAMH, Standard NR.02.02.01, EP 3). Therefore, we expect that TJC-
accredited hospitals already have the policies and procedures that 
satisfy the requirements in this subsection, including medical staff 
approval and annual review. If there are any tasks that a TJC-
accredited hospital may need to complete to satisfy the requirement for 
this subsection, we expect that the burden imposed would be negligible. 
Thus, for the approximately 3,900 TJC-accredited hospitals the 
development of policies and procedures that would satisfy this 
subsection would constitute a usual and customary business practice as 
defined at 5 CFR 1320.3(b)(2).
    The non TJC-accredited hospitals would need to review their current 
policies and procedures and update them so that they comply with the 
requirements in proposed Sec.  482.23(b). This would be a one-time 
burden on the hospital. We estimate that this would require a 
physician, a nurse, and one administrator. Physicians earn an average 
hourly salary of $187, administrators earn an average hourly salary of 
$174, and registered nurses earn an hourly salary of $68 (2014 BLS Wage 
Data by Area and Occupation at http://www.bls.gov/bls/blswage.htm, 
adjusted upward by 100 percent to include fringe benefits and overhead 
costs). We estimate that each person would spend three hours on this 
activity for a total of nine hours at a cost of $1,287 (3 hours x $68 
for a nurse's hourly salary + 3 hours x $174 for an administrator's 
hourly salary + 3 hours x $187 for a physician's hourly salary = 
$1,287). For all 1,000 non-TJC-accredited hospitals to comply with this 
requirement, we estimate a total one-time cost of approximately $1.3 
million (1,000 hospitals x $1,287). We estimate that annual review of 
the policies and procedures would take one hour for each individual 
included for a total annual cost of $429,000 ((1 hour x $68 for a 
nurse's hourly salary + 1 hour x $174 for an administrator's hourly 
salary + 1 hour x $187 for a physician's hourly salary) x 1,000 
hospitals). The burden associated with these requirements is captured 
in an information collection request (0938-NEW).

D. ICRs Regarding Medical Record Services (Sec.  482.24)

    We are proposing to make changes to several of the provisions in 
this CoP so that the requirements are clearer regarding the 
distinctions between a patient's inpatient and outpatient status and 
the subtle differences between certain aspects of medical record 
documentation related to each status.
    The current requirements at Sec.  482.24(c) state that the content 
of the medical record must contain ``information to justify admission 
and continued hospitalization, support the diagnosis, and describe the 
patient's progress and response to medications and services.'' While we 
believe that these terms are appropriate for inpatients, they do not 
fully capture the specific documentation necessary for outpatients. 
Therefore, we propose to revise the current regulatory language to 
require that the content of the medical record must contain 
``information to justify all admissions and continued hospitalizations, 
support the diagnoses, describe the patient's progress and responses to 
medications and services, and document all inpatient and outpatient 
visits to reflect the scope of all services received by the patient.''
    Similarly, we propose to revise Sec.  482.24(c)(4)(ii) from the 
current requirement for documentation of ``admitting diagnosis'' to 
include ``all inpatient and outpatient diagnoses,'' which would include 
any admitting diagnoses. Within this same standard, we are proposing to 
update several terms to reflect more current terminology and standards 
of practice. Therefore, at Sec.  482.24(c)(4)(iv), we propose to 
require that the content of the record include ``documentation of 
complications, hospital-acquired conditions, healthcare-associated 
infections, and unfavorable reactions to drugs and anesthesia.'' We 
also propose changes to Sec.  482.24(c)(4)(vi) to add ``progress 
notes'' to the required documentation of ``practitioners' orders'' to 
emphasize the necessary documentation for both inpatients and 
outpatients. And we propose to add the phrase ``to reflect the scope of 
all services received by the patient.''
    Continuing under this standard detailing the contents of the 
medical record, we propose to make revisions to the final two 
provisions under this standard. We propose to change Sec.  
482.24(c)(4)(vii) to require that all patient medical records must 
document discharge and transfer summaries with outcomes of all 
hospitalizations, disposition of cases, and provisions for follow-up 
care for all inpatient and outpatient visits to reflect the scope of 
all services received by the patient. We believe that these changes 
would clarify the importance of discharge summaries for patients being 
discharged home as well as the importance of transfer summaries for 
patients being transferred to post-acute care facilities such as 
nursing homes or inpatient rehabilitation facilities. In addition, we 
recognize the distinction between the services received by inpatient 
and those received by outpatients by proposing to include language that 
distinguishes between the inpatient and the outpatient experiences.
    Finally, we emphasize the distinctions between discharges and 
transfers as well as between inpatients and outpatients by proposing to 
revise Sec.  482.24(c)(4)(viii) so that the content of the medical 
record would contain ``final diagnoses with completion of medical 
records within 30 days following all inpatient stays and within 7 days 
following all outpatient visits.''
    We believe that hospitals would need to review their current 
policies and procedures and update them so that they comply with the 
requirements in proposed Sec.  482.24(c). This would be a one-time 
burden on the hospital. We estimate that this would require a 
physician, a nurse, and one administrator. Physicians earn an average 
hourly salary of $187, administrators earn an average hourly salary of 
$174, and registered nurses earn an hourly salary of $68 (2014 BLS Wage 
Data by Area and Occupation at http://www.bls.gov/bls/blswage.htm, 
adjusted upward by 100 percent to include fringe benefits and overhead 
costs). We estimate that each person would spend three hours on this 
activity for a total of nine hours at a cost of $1,287 (3 hours x $68 
for a nurse's hourly salary + 3 hours x $174 for an administrator's 
hourly salary + 3 hours x $187 for a physician's hourly salary = 
$1,287). For all 4,900 hospitals to comply with this requirement, we 
estimate a total one-time cost of approximately $6.3 million (4,900 
hospitals x $1,287). The burden associated with these requirements is 
captured in an information collection request (0938-NEW).

E. ICRs Regarding Provision of Services (Sec.  485.635)

    Section 485.635(g) would require that a CAH not discriminate 
against patients or applicants for service on the basis of race, color, 
religion, national origin, sex (including gender identity), sexual 
orientation, or disability and that the

[[Page 39468]]

CAH establish and implement a written policy prohibiting discrimination 
against patients or applicants for service on the basis of race, color, 
religion, national origin, sex (including gender identity), sexual 
orientation, or disability. We propose to further require that each 
patient, and/or support person, where appropriate, be informed, in a 
language he or she can understand, of the right to be free from 
discrimination against them on any of the aforementioned bases (HHS OCR 
Compliance Review Initiative: ``Advancing Effective Communication In 
Critical Access Hospitals'' April 2013 http://www.hhs.gov/sites/default/files/ocr/civilrights/activities/agreements/compliancereview_initiative.pdf). The burden associated with this 
requirement is the time and effort necessary for a CAH to develop 
written policies and procedures with respect to the rights of patients 
to be free from discrimination and to distribute that information to 
the patients.
    We estimate that 1,328 CAHs must comply with the aforementioned 
information collection requirements. We further estimate that it will 
take each CAH 0.25 hours to comply with the requirement in proposed 
Sec.  485.635(g). The total estimated annual burden associated with 
this requirement is 332 hours (1,328 hospitals x .25) at a cost of 
$22,576 (332 hours x $68 for a nurse's hourly salary).

F. ICRs Regarding Condition of Participation: Quality Assessment and 
Performance Improvement Program (Sec.  485.641)

    Proposed Sec.  485.641 would require CAHs to develop, implement, 
and maintain an effective, ongoing, CAH-wide, data-driven QAPI program. 
The QAPI program must be appropriate for the complexity of the CAH's 
organization and the services it provides. In addition, CAHs must 
comply with all of the requirements set forth in proposed Sec.  
485.641(b) through (g).
    The current CAH CoPs at Sec.  485.641 require CAHs to have an 
effective quality assurance program to evaluate the quality and 
appropriateness of the diagnosis and treatment furnished in the CAH and 
the treatment outcomes. CAHs are currently required to conduct a 
periodic evaluation and quality assurance review (42 CFR 485.641(a)). 
They are required to evaluate its total program (for example, policies 
and procedures and services provided) annually. The evaluation must 
include reviewing the utilization of the CAH services using a 
representative sample of both active and closed clinical records, as 
well as reviewing the facility's health care policies. The purpose of 
the evaluation is to determine whether the utilization of services was 
appropriate, the established policies were followed, and if any changes 
are needed. The CAH's staff considers the findings of the evaluation 
and takes corrective action, if necessary (42 CFR 485.641(b)(5)(i)). 
Thus, we believe that all of the CAHs are performing the activities 
that are required to comply with many of the requirements in proposed 
Sec.  485.641. However, we also believe that the CAHs would need to 
review their current quality assurance program and revise and, if 
needed, develop new provisions to ensure compliance with the proposed 
requirements.
    TJC accreditation standards for performance improvement (PI) 
already require that CAHs collect, compile, and analyze to monitor 
their performance (TJC Accreditation Standard PI.01.01.01 and 
PI.02.01.01). These TJC-accredited CAHs must also improve their 
performance on an ongoing basis (TJC Accreditation Standard 
PI.03.01.01). Thus, we believe that the 324 TJC-accredited CAHs are 
already in compliance with the requirements in proposed Sec.  485.641. 
However, each CAH would need to review their current practice to ensure 
that they are in compliance with all of the requirements under Sec.  
485.641. Any additional tasks those CAHs would need to comply with the 
requirements for this section should result in a negligible burden, if 
any. Thus, the burden for these activities for the 324 TJC-accredited 
CAHs will be excluded from the burden analysis because they constitute 
usual and customary business practices in accordance with 5 CFR 
1320.3(b)(2).
    The 1,004 non TJC-accredited CAHs would need to review their 
current programs and then revise and develop new provisions of their 
programs to ensure compliance with the proposed requirements. We 
believe that the CAH QAPI leadership (consisting of a physician, and/or 
administrator, mid-level practitioner, and a nurse) would need to have 
at least two meetings to ensure that the current annual evaluation and 
quality assurance (QA) program is transitioned into the proposed QAPI 
format. The first meeting would be to discuss the current quality 
assurance program and what needs to be included based on the new 
proposed QAPI provision. The second meeting would be to discuss 
strategies to update the current policies, and then to discuss the 
process for incorporating those changes. We believe that these meeting 
would take approximately two hours each. We would estimate that the 
physician would have a limited amount of time, approximately 1 hour to 
devote to the QAPI activities. Additionally, we estimate these 
activities would require 4 hours of an administrator's time, 4 hours of 
a mid-level practitioner's time, 14 hours of a nurse's time, and 2 
hours of a clerical staff person's time for a total of 25 burden hours. 
We believe that the CAH's QAPI leadership (formerly the periodic 
evaluation and quality assurance leadership) would need to meet 
periodically to review and discuss the changes that would need to be 
made to their program. We also believe that a nurse would likely spend 
more time developing the program with the mid-level practitioner. The 
physician would likely review and approve the program. The clerical 
staff member would probably assist with the program's development and 
ensure that the program was disseminated to all of the necessary 
parties in the CAH.
    Since a CAH is currently required to evaluate its total program and 
evaluate the quality and appropriateness of the services furnished, 
take appropriate action to address deficiencies and document such 
activities, we believe that the resources utilized on the current QA 
program would be utilized for the ongoing QAPI activities under 
proposed Sec.  485.641(b)-(f). Thus, we estimate that for each CAH to 
comply with the requirements in this section it would require 25 burden 
hours (1 for a physician + 4 for an administrator + 4 for a mid-level 
practitioner + 14 for a nurse + 2 for a clerical staff person = 25 
burden hours) at a cost of $1,975 ($187 for a physician + $392 for an 
administrator (4 hours x $98) + $380 for a mid-level practitioner (4 
hours x $95) + $952 (14 hours x $68 for a nurse) + $64 for a clerical 
staff person (2 hours x $32). Therefore, for all 1,004 non TJC-deemed 
CAHs to comply with these requirements, it would require 25,100 burden 
hours (25 x 1,004 non TJC-deemed CAHs) at a cost of approximately $2 
million ($1,975 for each CAH x 1,004 non TJC-deemed CAHs). We note here 
the difference in hourly salary between a hospital CEO/administrator 
($174) and a CAH CEO/administrator ($98). The burden associated with 
these requirements is captured in an information collection request 
(0938-NEW).
    If you comment on these information collection and recordkeeping 
requirements, please do either of the following:
    1. Submit your comments electronically as specified in the 
ADDRESSES section of this proposed rule; or

[[Page 39469]]

    2. Submit your comments to the Office of Information and Regulatory 
Affairs, Office of Management and Budget, Attention: CMS Desk Officer, 
CMS-3295-P, Fax: (202) 395-6974; or Email: [email protected].

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

    CMS is aware, through conversations with stakeholders and federal 
partners, and as a result of internal evaluation and research, of 
outstanding concerns about CoPs for hospitals and CAHs, despite recent 
revisions. We believe that the proposed revisions would alleviate many 
of those concerns. In addition, modernization of the requirements would 
cumulatively result in improved quality of care and improved outcomes 
for all hospital and CAH patients. We believe that benefits would 
include reduced readmissions, reduced incidence of hospital-acquired 
conditions (including healthcare-associated infections), improved use 
of antibiotics at reduced costs (including the potential for reduced 
antibiotic resistance), and improved patient and workforce protections.
    These benefits are consistent with current HHS Quality Initiatives, 
including efforts to prevent HAIs; the national action plan for adverse 
drug event (ADE) prevention; the national strategy for Combating 
Antibiotic-Resistant Bacteria (CARB); and the Department's National 
Quality Strategy (http://www.ahrq.gov/workingforquality/index.html). 
Principles of the National Quality Strategy supported by this proposed 
rule include eliminating disparities in care; improving quality; 
promoting consistent national standards while maintaining support for 
local, community, and State-level activities that are responsive to 
local circumstances; care coordination; and providing patients, 
providers, and payers with the clear information they need to make 
choices that are right for them (http://www.ahrq.gov/workingforquality/nqs/principles.htm). Our proposal to prohibit discrimination would 
support eliminating disparities in care, and we believe our proposals 
about QAPI and infection prevention and control and antibiotic 
stewardship programs will improve quality and promote consistent 
national standards. Our proposals regarding the term licensed 
independent practitioners and establishing policies and protocols for 
when the presence of an RN is needed will support care coordination and 
quality of care. In sum, we believe our proposed changes are necessary, 
timely, and beneficial.

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 (March 22, 
1995; Pub. L. 104-4), Executive Order 13132 on Federalism (August 4, 
1999) and the Congressional Review Act (5 U.S.C. 804(2)).
    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 
Regulatory Impact Analysis (RIA) that, to the best of our ability, 
presents the costs and benefits of the rulemaking.
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each chamber of the Congress and to the Comptroller General of the 
United States. HHS will submit a report containing this rule and other 
required information to the U.S. Senate, the U.S. House of 
Representatives, and the Comptroller General of the United States prior 
to publication of the rule in the Federal Register.
    This proposed rule would create ongoing cost savings to hospitals 
and CAHs in many areas. We believe these savings would largely, but not 
entirely, offset any costs to hospitals and CAHs that would be incurred 
by other changes we have proposed in this rule. The financial savings 
and costs are summarized in the table that follows. We welcome public 
comments on all of our burden assumptions and estimates. As discussed 
later in this regulatory impact analysis, substantial uncertainty 
surrounds these estimates and we especially solicit comments on either 
our estimates of likely savings/costs or the specific regulatory 
changes that drive these estimates.

                              Table 1--Section-by-Section Economic Impact Estimates
----------------------------------------------------------------------------------------------------------------
                                                                  Number of
                Issue                        Frequency            affected      Likely savings (+) or costs (-)
                                                                  entities          to society ($ millions)
----------------------------------------------------------------------------------------------------------------
Hospitals...........................  .......................           4,900
     Patients' rights (ICR).  One-time...............           4,900  0.083(-)

[[Page 39470]]

 
     Nursing services (ICR).  Recurring Annually.....           1,000  1.3(-)
     Nursing services (ICR).  One-time...............           1,000  0.429(-)
     Medical record services  One-time...............           4,900  6.3(-)
     (ICR).                                                             4,900  20(-)
     Infection Prevention &   One-time...............           2,940  >693 to 1,193(-)
     Control and Antibiotic           Recurring annually.....  ..............  .................................
     Stewardship (RIA).               Recurring Annually.....           2,940  1,020(+)
CAHs................................  .......................           1,328
     Provision of services    One-time...............           1,328  0.023(-)
     (ICR).
     QAPI (ICR).............  Recurring annually.....           1,004  2(-)
     Food and dietary (RIA).  Recurring annually.....             650  Not estimated
     Infection Prevention &   One-time...............           1,328  5(-)
     Control and Antibiotic           Recurring Annually.....           1,328  45(-)
     Stewardship (RIA).               Recurring Annually.....           1,328  37(+)
    Sub-Total Savings...............  .......................  ..............  1,057(+)
    Sub-Total Costs.................  .......................  ..............  >773 to 1,273(-)
    Overall Savings Net of Costs....  .......................  ..............  <-216 to 284(+)
----------------------------------------------------------------------------------------------------------------
Note: This table includes entries only for those proposed reforms that we believe would have a measurable
  economic effect; includes estimates from ICRs and RIAs.

C. Anticipated Effects

1. Effects on Hospitals and CAHs
    There are about 4,900 hospitals and 1,300 CAHs that are certified 
by Medicare and/or Medicaid. We use these figures to estimate the 
potential impacts of this proposed rule. In the estimates that were 
shown in the Collection of Information Requirements section of the 
preamble and in the Regulatory Impact Analysis here, we estimate hourly 
costs as follows. Using data from the Bureau of Labor Statistics, we 
have estimates of the national average hourly wage for all medical 
professions (for an explanation of these data see http://www.bls.gov/news.release/archives/ocwage_03252015.htm). These data do not include 
the employer share of fringe benefits such as health insurance and 
retirement plans, the employer share of OASDI taxes, or the overhead 
costs to employers for rent, utilities, electronic equipment, 
furniture, human resources staff, and other expenses that are incurred 
for employment. The HHS-wide practice is to account for all such costs 
by adding 100 percent to the hourly cost rate, doubling it for purposes 
of estimating the costs of regulations. We use the following average 
hourly wages for registered dietitians and nutrition professionals, 
registered nurses, advanced practice registered nurses, physician 
assistants, pharmacists, network data analysts, hospital CEO/
administrators, CAH CEO/administrators, clerical staff workers, and 
physicians respectively: $56, $68, $95, $95, $113, $70, $174, $98, $30, 
and $187 (2014 BLS Wage Data by Area and Occupation, including both 
hourly wages and fringe benefits, at http://www.bls.gov/bls/blswage.htm 
and http://www.bls.gov/ncs/ect/).
Licensed Independent Practitioners (Patients' Rights Sec.  482.13)
    We propose to delete the modifying term ``independent'' from the 
CoP at Sec.  482.13(e)(5), as well as at Sec.  482.13(e)(8)(ii). 
Therefore, we are proposing that Sec.  482.13(e)(5) would now state 
that the use of restraint or seclusion must be in accordance with the 
order of a physician or other licensed practitioner who is responsible 
for the care of the patient and authorized to order restraint or 
seclusion by hospital policy in accordance with State law. We are 
proposing that Sec.  482.13(e)(8)(ii) would now state that after 24 
hours, before writing a new order for the use of restraint or seclusion 
for the management of violent or self-destructive behavior, a physician 
or other licensed practitioner who is responsible for the care of the 
patient and authorized to order restraint or seclusion by hospital 
policy in accordance with State law must see and assess the patient. 
While we believe that hospitals might be able to achieve some costs 
savings through these changes (by having additional licensed 
practitioners such as PAs allowed to write restraint and seclusion 
orders and thus relieve some of the burden from physicians), we do not 
have a reliable means of quantifying these possible cost savings. We 
seek comment as to whether the assumption of cost savings is reasonable 
and welcome any data that may help inform the costs and benefits of 
this provision.
Infection Control and Antibiotic Stewardship (Infection Prevention and 
Control Sec.  482.42)
    We are revising the hospital requirements at 42 CFR 482.42, 
``Infection control,'' which currently require hospitals to provide a 
sanitary environment to avoid sources and transmission of infections 
and communicable diseases. Hospitals are also currently required to 
have a designated infection control officer, or officers, who are 
required to develop a system to identify, report, investigate and 
control infections and communicable diseases of patients and personnel. 
The hospital's CEO, medical staff, and director of nursing services are 
charged with ensuring that the problems identified by the infection 
control officer or officers are addressed in hospital training programs 
and their QAPI program. The CEO, medical staff, and director of nursing 
services are also responsible for the implementation of successful 
corrective action plans in affected problem areas.
    We are proposing a change to the title of this CoP to ``Infection 
prevention and control and antibiotic stewardship programs.'' By adding 
the word ``prevention'' to the CoP name, our intent is to promote 
larger, cultural changes in hospitals such that prevention initiatives 
are recognized on balance with their current, traditional control 
efforts. And by adding ``antibiotic stewardship'' to the title, we 
would emphasize the important role that a hospital could play in 
improving patient care and safety and combatting antimicrobial 
resistance through implementation of a robust stewardship

[[Page 39471]]

program that follows nationally recognized guidelines for appropriate 
antibiotic use. Along with these changes, we propose to change the 
introductory paragraph to require that a hospital's infection 
prevention and control and antibiotic stewardship programs be active 
and hospital-wide for the surveillance, prevention, and control of HAIs 
and other infectious diseases, and for the optimization of antibiotic 
use through stewardship. We would also require that a program 
demonstrate adherence to nationally recognized infection prevention and 
control guidelines for reducing the transmission of infections, as well 
as best practices for improving antibiotic use, for reducing the 
development and transmission of HAIs and antibiotic-resistant 
organisms. While these particular changes are new to the regulatory 
text, it is worth noting that these requirements, with the exception of 
the new requirement for an antibiotic stewardship program, have been 
present in the Interpretive Guidelines (IGs) for hospitals since 2008 
(See A0747 at Appendix A--Survey Protocol, Regulations and Interpretive 
Guidelines for Hospitals, http://cms.gov/manuals/Downloads/som107ap_a_hospitals.pdf).
Infection Prevention and Control
    Specifically, at Sec.  482.42(a)(1), we propose to require the 
hospital to appoint an infection preventionist(s)/infection control 
professional(s). Within this proposed change we are deleting the 
outdated term, ``infection control officer,'' and replacing it with the 
more current and accurate terms, ``infection preventionist/infection 
control professional.'' CDC has defined ``infection control 
professional (ICP)'' as ``a person whose primary training is in either 
nursing, medical technology, microbiology, or epidemiology and who has 
acquired specialized training in infection control.'' In designating 
infection preventionists/ICPs, hospitals should ensure that the 
individuals so designated are qualified through education, training, 
experience, or certification (such as that offered by the CBIC, or by 
the specialty boards in adult or pediatric infectious diseases offered 
for physicians by the American Board of Internal Medicine (for 
internists) and the American Board of Pediatrics (for pediatricians). 
Since this requirement has been present in the IGs since 2008, we 
believe that hospitals have been aware of CMS' expectations for the 
qualifications of infection control officers. The Joint Commission has 
a similar requirement (TJC Accreditation Standard IC.01.01.01) and so 
we believe that hospitals accredited by TJC (over 75 percent of all 
hospitals (http://www.jointcommission.org/facts_about_hospital_accreditation/)) would already be in compliance, 
or near compliance, with this requirement. The Joint Commission 
requires that a hospital identify the individual(s) responsible for its 
infection prevention and control program, including the individual(s) 
with clinical authority over the infection prevention and control 
program. For the 25 percent of hospitals not accredited by TJC, we are 
calculating the burden for these hospitals to come into compliance with 
this requirement.
    Based on our experience with hospitals, we believe that most ICPs 
would be registered nurses with experience, education, and training in 
infection control. Twenty-five percent of hospitals not accredited by 
TJC is 1,225 hospitals. Each hospital would be required to employ at 
least one ICP fulltime (52 weeks x 40 hours = 2,080 hours) at $68 per 
hour. The cost per hospital would be $141,440 annually (2,080 hours x 
$68 = $141,440). The total cost for all non-TJC-accredited hospitals 
would be approximately $173 million annually (1,225 x $141,440 = 
173,264,000).
    We believe that the other proposed requirements in this section of 
the CoP would constitute additional burden. Each hospital would be 
required to review their current infection control program and compare 
it to the new requirements contained in this section. After performing 
this comparison, each hospital would be required to revise their 
program so that it complied with the requirements in this section. 
Based on our experience with hospitals, we believe that a physician and 
a nurse on the infection control team would conduct this review and 
revision of the program. We believe both the physician and the nurse 
would spend 16 hours each for a total of 32 hours. Physicians earn an 
average of $187 an hour. Nurses earn an average salary of $68 an hour. 
Thus, to ensure their infection control program complied with the 
requirements in this section, we estimate that each hospital would 
require 32 burden hours (16 hours for a physician and 16 hours for a 
nurse = 32 burden hours) at a cost of $4,080 ($2,992 ($187 an hour for 
a physician x 16 burden hours) + $1,088 ($68 an hour for a nurse x 16 
burden hours)). Based on the estimate, for all 4,900 hospitals, 
complying with this requirement would require 156,800 burden hours (32 
hours for each hospital x 4,900 hospitals = 156,800 burden hours) at a 
one-time cost of approximately $20 million ($4,080 for each hospital x 
4,900 hospitals = $19,992,000 estimated cost).
Antibiotic Stewardship
    Similarly at Sec.  482.42(b), we believe that the proposed 
requirements for a hospital to have an active antibiotic stewardship 
program, and for its organization and policies, would constitute 
additional regulatory burden, as will be discussed in more detail 
below. However, we believe that the estimated costs of an AS program 
would be greatly offset by the savings that a hospital would achieve 
through such a program. The most obvious savings would be from 
decreased inappropriate antibiotic use leading to overall decreased 
drug costs for a hospital. Our review of the literature showed 
significant savings in this area, with annual savings proportional to 
bed size of the hospital or hospital unit. Reported annual savings 
ranged from $27,917 (Canadian dollars) for a 12-bed medical/surgical 
intensive care unit to $2.1 million for an 880-bed academic medical 
center (Leung V, Gill S, Sauve J, Walker K, Stumpo C, Powis J. Growing 
a ``positive culture'' of antimicrobial stewardship in a community 
hospital. The Canadian journal of hospital pharmacy. 2011; 64(5):314-
20; Beardsley JR, Williamson JC, Johnson JW, Luther VP, Wrenn RH, Ohl 
CC. Show me the money: Long-term financial impact of an antimicrobial 
stewardship program. Infection control and hospital epidemiology: The 
official journal of the Society of Hospital Epidemiologists of America. 
2012; 33(4):398-400). We specifically note the $177,000 in annual drug 
cost savings achieved by a 120-bed community hospital with its AS 
program and would use that as the average cost savings for the average-
sized 124-bed hospital discussed above (LaRocco 2003, CID ``Concurrent 
antibiotic review programs-a role for infectious diseases specialists 
at small community hospitals''). Using this assumption, we believe that 
the annual drug cost savings for 60 percent of all 4,900 hospitals 
under this proposed rule would be $520,380,000 or approximately $520 
million (2,940 hospitals x $177,000 in drug cost savings).
    In addition to these savings, we also believe that the proposed 
requirement for an AS program would assist hospitals in significantly 
reducing rates of CDI and the attendant costs. Based on an AS program 
model developed by the CDC, a hospital combined IC/AS program with an 
average effectiveness rate of 50 percent would reduce the number of 
CDIs among Medicare beneficiaries annually by 101,000

[[Page 39472]]

(Rachel B. Slayton, Ph.D., MPH; R. Douglas Scott II, Ph.D.; James 
Baggs, Ph.D.; Fernanda C. Lessa, MD; L. Clifford McDonald, MD; John A. 
Jernigan, MD. ``The Cost-Benefit of Federal Investment in Preventing 
Clostridium difficile Infections through the Use of a Multifaceted 
Infection Control and Antimicrobial Stewardship Program,'' Infection 
Control & Hospital Epidemiology 2015;00(0):1-7). The costs examined in 
the model were costs for patients who developed CDIs while they were in 
the hospital or had to be re-admitted to the hospital for a case of CDI 
that was a result of a recent hospitalization, so the costs are much 
higher than what would be associated with outpatient cases. The 
101,000-reduction is an annual reduction in the number of cases of CDI 
among patients who develop the infection because of medical care; that 
is, they were admitted for something else and then acquired CDI while 
getting care. It should be noted that the 101,000 number actually 
comprises two types of CDI--cases that occur while the patient is in 
the hospital and cases that are directly attributable to a recent 
hospitalization, but which manifest after the patient is discharged and 
requires a readmission. The cost for patients who develop the infection 
while they are already in the hospital is between $4,323 and $8,146. 
However, the infections related to a recent hospital stay that require 
readmission are more expensive, on average, because they require an 
entirely new admission. The cost of those cases is between $7,061 and 
$11,601. Slayton et al. estimate $2.5 billion in federal savings over 
five years, or an annual average of $0.5 billion.\2\ We believe that 
the combined annual savings that hospitals could achieve with the 
proposed AS program and the proposed revisions to infection control 
would be $1,020,000,000 or $1 billion.
---------------------------------------------------------------------------

    \2\ Slayton et al. appear not to account for the increased 
Medicare costs that would result from IC/AS program-associated 
reductions in CDI-related deaths. Although such an accounting would 
be appropriate to include in this regulatory impact analysis, its 
negative effect on estimated net benefits would almost certainly be 
more than offset by the inclusion of a willingness-to-pay estimate 
of the value of life extension. Willingness-to-pay approaches can 
also be used to monetize the decrease in pain and suffering 
associated with reductions in non-fatal morbidity, so we request 
data that would allow for more thorough estimation of all of these 
effects (i.e., the societal benefits of reduced non-fatal CDI 
illness and the societal benefits and costs of reduced fatal CDI 
illness).
---------------------------------------------------------------------------

    We note that these savings would be both to hospitals as well as 
healthcare insurers, including Medicare. However, we are not able to 
distinguish the savings that would accrue to each group in this 
analysis. Healthcare-associated infections are known to be expensive to 
insurers, including CMS. Preventing these infections will reduce CMS 
and other insurer expenditures, both on direct hospital costs and 
through reduced re-admissions. The cost-savings estimates for CDI 
included in the RIA provide an example of the savings Medicare and 
other insurers could realize through reductions in just one HAI.\3\
---------------------------------------------------------------------------

    \3\ We invite data that would allow for quantification of the 
rule's impacts on HAIs other than CDI.
---------------------------------------------------------------------------

    We anticipate that the drug savings accrue to the hospitals. The 
CDI savings are likely shared by hospitals and insurers. Hospitals do 
bear some of these costs of CDI infections, especially if the CDI case 
complicates a hospitalization--for example if a patient admitted for 
pneumonia gets CDI, under bundled payment rules, the hospital would 
likely make less money from that admission. Also, CDI now also factors 
into annual payment updates under the inpatient quality reporting 
program, so hospitals with high CDI rates could face payment 
reductions.
    We believe that the burden of implementing and maintaining an AS 
program includes the salaries of the qualified personnel needed to 
establish and manage such a hospital program. Our review of the 
literature, consultations with CDC, and experience with hospitals 
suggests that the establishment and maintenance of a hospital 
antibiotic stewardship program as proposed here, for an average-size 
hospital (approximately 124 beds), would require the services of a 
physician (preferably one with training in infectious diseases) and a 
clinical pharmacist, and also a network data analyst, at the following 
proportions of full-time employee salaries respectively: 0.10, 0.25, 
and 0.05. We believe that these personnel costs would constitute the 
real burden for these proposed requirements. To determine the cost of 
this burden, we added the proportion of full-time salaries required of 
a physician, a clinical pharmacist, and a network analyst. We also 
based our estimates on the assumption that 60 percent of hospitals do 
not yet have programs that implement all of the CDC core elements 
(based on data from the 2015 NHSN survey). Based on these assumptions, 
the total annual cost for a hospital to establish and maintain an 
antibiotic stewardship program would be $100,900 (($187 x 0.10 x 2,000 
hours per year = $37,400 for a physician) + ($113 x 0.25 x 2,000 hours 
per year = $56,500 for a clinical pharmacist) + ($70 per hour x 0.05 x 
2,000 hour per year = $7,000 for a network data analyst)). The total 
annual labor cost for 60 percent of hospitals ($100,900 x 2,940) would 
be approximately $297 million.
    As shown above, however, we estimate that the drug cost savings of 
implementing and maintaining IC/AS programs would be $520.4 million. 
For hospitals to not have voluntarily implemented such programs 
indicates that their costs are at least as great as their savings; 
therefore, either labor costs are underestimated at $297 million or 
there are non-labor costs involved in the implementation and 
maintenance of IC/AS programs. We therefore estimate $520.4 million as 
a lower bound on the costs associated with this provision of the 
proposed rule. Moreover, as discussed previously, non-drug cost savings 
may also accrue to hospitals; if so, then lack of voluntary 
implementation indicates that costs associated with this provision 
would be at least $1.0 billion. We invite public comment regarding the 
amount by which costs exceed savings in cases of non-voluntary IC/AS 
program adoption.
Ordering Privileges for Qualified Dietitians (RDs) and Qualified 
Nutrition Professionals (Provision of Services Sec.  485.635)
    We propose to revise the CAH requirements at 42 CFR 
485.635(a)(3)(vii), which currently requires that the nutritional needs 
of inpatients are met in accordance with recognized dietary practices 
and the orders of the practitioner responsible for the care of the 
patients. Specifically, we are proposing revisions that would change 
the CMS requirements to allow for flexibility in this area by requiring 
that all patient diets, including therapeutic diets, must be ordered by 
a practitioner responsible for the care of the patient, or by a 
qualified dietitian or qualified nutrition professional as authorized 
by the medical staff in accordance with State law governing dietitians 
and nutrition professionals.
    With these proposed changes to the current requirements, a CAH 
would have the regulatory flexibility to grant qualified dietitians/
nutrition professionals specific dietary ordering privileges (including 
the capacity to order specific laboratory tests to monitor nutritional 
interventions and then modify those interventions as needed). We 
believe that this is another area of change to the requirements that 
might produce savings since our proposal would allow physicians to 
delegate to a qualified dietitian or qualified nutrition professional 
the task of prescribing patient diets, including therapeutic diets, to 
the extent allowed by state law.

[[Page 39473]]

We further believe that dietitians or other clinically qualified 
nutrition professionals are already performing patient dietary 
assessments and making dietary recommendations to the physician (or PA 
or APRN) who then evaluates the recommendations and writes orders to 
implement them. Our analysis does not take into account improved 
quality of life nor improved clinical outcomes for the patient. We do 
not currently have data to more precisely estimate the savings that 
this proposed revision could produce in CAHs. We welcome commenters to 
provide data that might assist in a more precise estimate. However, we 
believe that it might allow for better use of both physician/PA/APRN 
and dietitian/nutrition professional time and could result in improved 
quality of life and improved clinical outcomes for CAH patients.
    More obviously, dietitians/nutrition professionals with ordering 
privileges would be able to provide dietary/nutritional services at 
lower costs than physicians (as well as APRNs and PAs, two categories 
of non-physician practitioners that have traditionally also devised and 
written patient dietary plans and orders). This cost savings stems in 
some part from significant differences in the average salaries between 
the professions and the time savings achieved by allowing dietitians/
nutrition professionals to autonomously plan, order, monitor, and 
modify services as needed and in a more complete and timely manner than 
they are currently allowed. Savings would be realized by CAHs through 
the physician/APRN/PA time and salaries saved.
    Physicians, APRNs, and PAs often lack the training and educational 
background to manage the nutritional needs of patients with the same 
efficiency and skill as dietitians/nutrition professionals. The 
addition of ordering privileges enhances the ability that dietitians/
nutrition professionals already have to provide timely, cost-effective, 
and evidence-based nutrition services as the recognized nutrition 
experts on a CAH interdisciplinary team.
    It might seem natural to calculate these cost savings for CAHs 
based on the following assumptions:
     There is an average hourly cost difference of $70 between 
dietitians/nutrition professionals on one side ($56 per hour) and the 
hourly cost average for physicians, APRNs, and PAs ($126 per hour) on 
the other;
     There were 282,584 inpatient visits by Medicare 
beneficiaries in 2011 (According to a December 2013 OIG report (http://oig.hhs.gov/oei/reports/oei-05-12-00081.pdf)) with each of these stays 
requiring at least one dietary plan and orders;
     On average, each dietary order, including ordering and 
monitoring of laboratory tests, subsequent modifications to orders, and 
dietary orders for discharge/transfer/outpatient follow-up as needed, 
will take 30 minutes (0.5 hours) of a physician's/APRN's/PA's/
dietitian's/nutrition professional's time per patient during an average 
stay; and
     We estimate that approximately 50 percent of CAHs (or 
approximately 650 CAHs) have not already granted ordering privileges to 
dietitians and nutrition professionals, reducing the number of total 
number of CAH inpatient stays to 141,292.
    The resulting savings would be $7,608 annually on average for each 
CAH (141,292 inpatient hospital stays x 0.50 hours of a physician's/
APRN's/PA's/dietitian's/nutrition professional's time x $70 per hourly 
cost difference / 650 CAHs) for a total annual savings of approximately 
$5 million. We note that these estimates exclude some categories of 
cost increases (for example, internal CAH meetings to plan changes and 
the time and other costs of training physicians, dietitians/nutrition 
professionals, and other staff on the new dietary ordering procedures). 
Even more importantly, this estimate does not account for barriers, 
other than federal regulation, to RDs receiving ordering privileges; 
Weil et al. (2008) provide evidence on the existence of such barriers, 
which would likely prevent at least some of these cost savings from 
being realized.\4\ If such barriers are not relevant, then there is 
another adjustment that would need to be made to the calculation. 
Specifically, the dietitian wage estimate would need to be revised 
because the May 2014 wage data do not account for the increase in 
demand for dietitians we projected would result from the hospital 
burden reduction rule finalized that same month. For the savings 
estimates accompanying that rule to be achieved would require at least 
6.7 percent of the dietitian FTEs in the U.S. to be newly allocated to 
providing nutrition services to hospital patients.\5\ This shift in 
activity entails a substantial movement along the supply curve for 
dietitian labor, thus raising the dietitian wage and reducing the cost 
savings estimated with the method outlined. For these reasons, as well 
as our lack of data on CAH outpatient visits for nutritional services 
and the impact that the proposed regulatory changes might have on 
hospital costs in this area, we present the $10 million estimate for 
discussion purposes only and do not include it in the summary estimates 
of costs and cost savings attributable to the proposed rule.
---------------------------------------------------------------------------

    \4\ Weil, Sharon D., et al. ``Registered Dietitian Prescriptive 
Practices in Hospitals.'' Journal of the American Dietetic 
Association 108:1688-1692. October 2008.
    \5\ BLS data show employment of 59,490 dietitians, with a mean 
hourly wage of $27.62. Assuming all dietitians are employed full-
time (2,080 hours annually) yields a total sector value of $3.4 
billion, or $6.8 billion when doubled to account for fringe benefits 
and overhead. For the May, 2014, final rule, we estimated $459 
million of loaded wage savings associated with dietary ordering 
switching from physicians, nurse practitioners and physician 
assistants to lower-paid dietitians. Thus the relevant portion of 
the savings estimate equals roughly 6.7 percent (= $459 million / 
$6.8 billion) of the sector as a whole--and would exceed 6.7 
percent, to the extent that some current dietitian positions are 
part-time.
---------------------------------------------------------------------------


Sec.  485.640  Condition of participation: Infection prevention and 
control and antibiotic stewardship programs

    As we proposed for hospitals, we are also proposing new infection 
prevention and control and antibiotic stewardship requirements for 
CAHs. The infection control requirements for CAHs have remained 
unchanged since 1997. We are adding a new infection prevention and 
control (as well as antibiotic stewardship) CoP for CAHs because the 
existing standards for infection control do not reflect the current 
nationally recognized practices for the prevention and elimination of 
healthcare-associated infections.
Infection Prevention and Control
    Each CAH would be required to review their current infection 
control program and compare it to the new requirements contained in 
this section. After performing this comparison, each CAH would be 
required to revise their program so that it complied with the 
requirements in this section. Based on our experience with CAHs, we 
believe that a physician and a nurse on the infection control team 
would conduct this review and revision of the program. We believe both 
the physician and the nurse would spend 16 hours each for a total of 32 
hours. Physicians earn an average of $187 an hour. Nurses earn an 
average salary of $68 an hour. Thus, to ensure their infection control 
program complied with the requirements in this section, we estimate 
that each CAH would require 32 burden hours (16 hours for a physician 
and 16 hours for a nurse = 32 burden hours) at a cost of $4,080 ($2,992 
($187 an hour for a physician x 16 burden hours = $2,292) + $1,088($68 
an hour for a nurse x 16

[[Page 39474]]

burden hours = $1,088) = $4,080 estimated cost). Based on the estimate, 
for all 1,300 CAHs, complying with this requirement would require 
41,600 burden hours (32 hours for each CAH x 1,300 CAHs = 41,600 burden 
hours) at a one-time cost of approximately $5 million ($4,080 for each 
CAH x 1,300 CAHs = $5,304,000 estimated cost).
Antibiotic Stewardship
    Similarly, we believe that the proposed requirements for a CAH to 
have an active antibiotic stewardship program, and for its organization 
and policies, would constitute additional regulatory burden. However, 
we believe that the burden of implementing and maintaining an AS 
program includes the salaries of the qualified personnel needed to 
establish and manage such a CAH program. Our review of the literature, 
consultations with CDC, and experience with CAHs suggests that the 
establishment and maintenance of a CAH antibiotic stewardship program 
as proposed here, for a statutorily mandated 25-bed CAH, would require 
the services of a physician (preferably an infectious disease physician 
or physician with training in antibiotic stewardship) and a clinical 
pharmacist (preferably with training in infectious diseases or 
antibiotic stewardship), and also a network data analyst at the 
following proportions of full-time employee salaries respectively: 
0.05, 0.10, and 0.025. We believe that these personnel costs would 
constitute a real burden for these proposed requirements. To determine 
the cost of this burden, we have added the proportion of full-time 
salaries required of a physician, a clinical pharmacist, and a network 
analyst. Based on these assumptions, the total annual cost for a CAH to 
establish and maintain an antibiotic stewardship program would be 
$44,800 (($187 per hour x 0.05 x 2,000 hours per year = $18,700 for a 
physician) + ($113 per hour x 0.10 x 2,000 hours per year = $22,600 for 
a clinical pharmacist) + ($70 per hour x 0.025 x 2,000 hours per year = 
$3,500 for a network data analyst)). According to CDC, 97 of 397 (or 
approximately 24 percent) of hospitals with fewer than 25 beds reported 
having an AS program that meets all of the CDC's core elements. 
However, we have no way of determing from the data how many of these 
less-than-25-bed hospitals are actually CAHs. For the purposes of this 
burden estimate, we assume that 24 percent of the total 1,328 CAHs (or 
approximately 319 CAHs) have already implemented an AS program. 
Therefore, 1,009 CAHs have not implemented an AS program. The total 
annual cost for these CAHs (x 1,009) would be approximately $45 
million.
    However, we believe that the estimated costs of an AS program would 
be somewhat offset by the savings that a CAH would achieve through such 
a program. The most obvious savings would be from decreased 
inappropriate antibiotic use leading to overall decreased drug costs 
for a CAH. Our review of the literature showed significant savings in 
this area, with annual savings proportional to bed size of the 
hospital. Reported annual savings ranged from $27,917 for a 12-bed 
medical/surgical intensive care unit to $2.1 million for an 880-bed 
academic medical center. We specifically note the $177,000 in annual 
drug cost savings achieved by a 120-bed community hospital with its AS 
program (LaRocco 2003, CID ``Concurrent antibiotic review programs-a 
role for infectious diseases specialists at small community CAHs'') and 
would use that as the basis to calculate average annual cost savings 
for a 25-bed CAH ($177,000 annual savings / 120 beds = $1,475 annual 
cost savings per bed) at $36,875 per CAH ($1,475 annual cost savings x 
25 beds). Using this assumption, we believe that the annual drug cost 
savings for 1,009 CAHs under this proposed rule would be approximately 
$37 million (1,009 CAHs x $36,875 in drug cost savings).
    In addition to these savings, we also believe that the proposed 
requirement for an AS program would assist CAHs in significantly 
reducing rates of CDI and the attendant costs. Based on an AS program 
model developed by the CDC, a CAH combined IC/AS program with an 
average effectiveness rate of 50 percent would reduce the number of 
CDIs among Medicare beneficiaries annually by 101,000. However, we do 
not have a reliable means to distinguish this cost savings for CAHs 
from the cost savings for hospitals that we have already calculated.
2. Effects on Small Entities
    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 the 
great majority of the providers that would be affected by CMS rules are 
small entities as that term is used in the RFA. The great majority of 
hospitals and most other healthcare providers and suppliers are small 
entities, either by being nonprofit organizations or by meeting the SBA 
definition of a small business. Accordingly, the usual practice of HHS 
is to treat all providers and suppliers as small entities in analyzing 
the effects of our rules.
    This proposed rule would cost affected entities approximately $0.6 
to 1.1 billion a year, largely, but not entirely, offset by savings. 
While this is a large amount in total, the average cost per affected 
hospital is less than one half million dollars per year. Although the 
overall magnitude of the paperwork, staffing, and related cost 
reductions to hospitals and CAHs under this rule is economically 
significant, these savings are likely to be a fraction of one percent 
of total hospital costs. Total national inpatient hospital spending is 
approximately nine hundred billion dollars a year, or an average of 
about $150 million per hospital, and our primary estimate of the net 
(though possibly not the gross) effect of these proposals on increasing 
hospital costs is less than $1 billion annually.
    Under HHS guidelines for RFA, actions that do not negatively affect 
costs or revenues by more than 3 percent a year are not economically 
significant. We believe that no hospitals of any size will be 
negatively affected to this degree. Accordingly, we have determined 
that this proposed rule would not have a significant economic impact on 
a substantial number of small entities, and certify that an Initial RFA 
is not required. Notwithstanding this conclusion, we believe that this 
RIA and the preamble as a whole meet the requirements of the RFA for 
such an analysis.
    In addition, section 1102(b) of the 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 preceding 
reasons, we have determined that this proposed rule will lead to net 
savings and will therefore not have a significant negative 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 2016, that 
is approximately $144 million. This proposed rule does not contain any 
mandates.

[[Page 39475]]

    Executive Order 13132 establishes certain requirements that an 
agency must meet when it issues a proposed rule (and subsequent final 
rule) that would impose substantial direct requirement costs on State 
and local governments, preempts State law, or otherwise has Federalism 
implications. This rule would not have a substantial direct effect on 
State or local governments, preempt States, or otherwise have a 
Federalism implication.

D. Alternatives Considered

    As we stated, CMS is aware, through conversations with stakeholders 
and federal partners, and as a result of internal evaluation and 
research, of outstanding concerns about the CoPs for hospitals and 
CAHs, despite recent revisions. This subset of the universe of 
standards is the focus of this proposed rule.
    One alternative we did consider was combining the infection 
prevention and control leader position with that of the antibiotic 
stewardship leader position. While this would certainly reduce the 
costs for hospitals by eliminating one of these positions, we also 
believe that it might reduce the overall effectiveness of the program 
and, thus, the overall societal benefits that might be achieved. The 
skills needed to lead each program are different. Infection prevention 
programs are often led by nursing staff who do not prescribe 
antibiotics. Antibiotic stewardship programs are led by physicians and 
pharmacists who have direct knowledge and experience with antibiotic 
prescribing. For these reasons, we decided to propose the requirement 
as it is contained in this rule.
    For all of the proposed provisions, we considered not making these 
changes. Ultimately, based on our analysis of these issues and for the 
reasons stated in this preamble, we believe that it is best to propose 
changes at this time. 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.

E. Accounting Statement and Table

    As required by OMB Circular A-4 (available at http://www.whitehouse.gov/omb/circulars/a004/a-4.pdf), we have prepared an 
accounting statement.

                  Table 2--Accounting Statement: Classification of Estimated Costs and Benefits
                                                 [$ In millions]
----------------------------------------------------------------------------------------------------------------
                                                                                       Units
                   Category                        Estimates     -----------------------------------------------
                                                                    Year dollar    Discount rate  Period covered
----------------------------------------------------------------------------------------------------------------
                                                    Benefits
----------------------------------------------------------------------------------------------------------------
Annualized...................................              1,057            2015              7%       2016-2020
Monetized ($million/year)....................              1,057            2015              3%       2016-2020
----------------------------------------------------------------------------------------------------------------
                 Qualitative                    Potential Reductions in morbidity and mortality for hospital and
                                                                          CAH patients
----------------------------------------------------------------------------------------------------------------
                                                     Costs *
----------------------------------------------------------------------------------------------------------------
Annualized...................................       748 to 1,248            2015              7%       2016-2020
Monetized ($million/year)....................       748 to 1,248            2015              3%       2016-2020
----------------------------------------------------------------------------------------------------------------

F. Conclusion

    The impact of this proposed rule lies primarily with the estimated 
costs (approximately $773 million to $1.1 billion) of revising the 
hospital and CAH infection control CoPs, including the new requirements 
for antibiotic stewardship programs. However, these costs may be more 
than offset by the savings, and the overall benefits to patients, that 
would be achieved with these changes (net savings to society of up to 
$284 million). The analysis, together with the remainder of this 
preamble, provides a Regulatory Impact Analysis and an Initial 
Regulatory Flexibility 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 482

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

42 CFR Part 485

    Grant programs--health, Health facilities, Medicaid, 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 482--CONDITIONS OF PARTICIPATION FOR HOSPITALS

0
1. 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
2. Section 482.13 is amended by revising paragraphs (d)(2), (e)(5), 
(e)(8)(ii), (e)(10), (e)(11), (e)(12)(i), (e)(14), and (g)(4)(ii) and 
by adding paragraph (i) to read as follows:


Sec.  482.13  Condition of participation: Patient's rights.

* * * * *
    (d) * * *
    (2) The patient has the right to access their medical records, upon 
an oral or written request, in the form and format requested by the 
individual, if it is readily producible in such form and format 
(including in an electronic form or format when such medical records 
are maintained electronically); or, if not, in a readable hard copy 
form or such other form and format as agreed to by the facility and the 
individual, including current medical records, within a reasonable time 
frame. The hospital must not frustrate the legitimate efforts of 
individuals to gain access to their own medical records and

[[Page 39476]]

must actively seek to meet these requests as quickly as its record 
keeping system permits.
    (e) * * *
    (5) The use of restraint or seclusion must be in accordance with 
the order of a physician or other licensed practitioner who is 
responsible for the care of the patient and authorized to order 
restraint or seclusion by hospital policy in accordance with State law.
* * * * *
    (8) * * *
    (ii) After 24 hours, before writing a new order for the use of 
restraint or seclusion for the management of violent or self-
destructive behavior, a physician or other licensed practitioner who is 
responsible for the care of the patient and authorized to order 
restraint or seclusion by hospital policy in accordance with State law 
must see and assess the patient.
* * * * *
    (10) The condition of the patient who is restrained or secluded 
must be monitored by a physician, other licensed practitioner, or 
trained staff that have completed the training criteria specified in 
paragraph (f) of this section at an interval determined by hospital 
policy.
    (11) Physician and other licensed practitioner training 
requirements must be specified in hospital policy. At a minimum, 
physicians and other licensed practitioners authorized to order 
restraint or seclusion by hospital policy in accordance with State law 
must have a working knowledge of hospital policy regarding the use of 
restraint or seclusion.
    (12) * * *
    (i) By a--
    (A) Physician or other licensed practitioner.
    (B) Registered nurse who has been trained in accordance with the 
requirements specified in paragraph (f) of this section.
* * * * *
    (14) If the face-to-face evaluation specified in paragraph (e)(12) 
of this section is conducted by a trained registered nurse, the trained 
registered nurse must consult the attending physician or other licensed 
practitioner who is responsible for the care of the patient as soon as 
possible after the completion of the 1-hour face-to-face evaluation.
* * * * *
    (g) * * *
    (4) * * *
    (ii) Each entry must document the patient's name, date of birth, 
date of death, name of attending physician or other licensed 
practitioner who is responsible for the care of the patient, medical 
record number, and primary diagnosis(es).
* * * * *
    (i) Standard: Non-discrimination. A hospital must meet the 
following requirements:
    (1) Not discriminate on the basis of race, color, religion, 
national origin, sex (including gender identity), sexual orientation, 
age, or disability.
    (2) Establish and implement a written policy prohibiting 
discrimination on the basis of race, color, religion, national origin, 
sex (including gender identity), sexual orientation, age, or 
disability.
    (3) Inform each patient (and/or support person, where appropriate), 
in a language he or she can understand, of his or her right to be free 
from discrimination against them and how to file a complaint if they 
encounter discrimination when he or she is informed of his or her other 
rights under this section.
0
3. Section 482.21 is amended by revising paragraph (b)(1) to read as 
follows:


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

* * * * *
    (b) * * *
    (1) The program must incorporate quality indicator data including 
patient care data, and other relevant data such as data submitted to or 
received from Medicare quality reporting and quality performance 
programs, including but not limited to data related to hospital 
readmissions and hospital-acquired conditions.
* * * * *
0
4. Section 482.23 is amended by revising paragraphs (b) introductory 
text, (b)(4) and (6), (c)(1) introductory text, and (c)(3), and by 
adding paragraph (b)(7) to read as follows:


Sec.  482.23  Condition of participation: Nursing services.

* * * * *
    (b) Standard: Staffing and delivery of care. The nursing service 
must have adequate numbers of licensed registered nurses, licensed 
practical (vocational) nurses, and other personnel to provide nursing 
care to all patients as needed. There must be supervisory and staff 
personnel for each department or nursing unit to ensure, when needed, 
the immediate availability of a registered nurse for the care of any 
patient.
* * * * *
    (4) The hospital must ensure that the nursing staff develops, and 
keeps current for each patient, a nursing care plan that reflects the 
patient's goals and the nursing care to be provided to meet the 
patient's needs. The nursing care plan may be part of an 
interdisciplinary care plan.
* * * * *
    (6) All licensed nurses who provide services in the hospital must 
adhere to the policies and procedures of the hospital. The director of 
nursing service must provide for the adequate supervision and 
evaluation of the clinical activities of all nursing personnel which 
occur within the responsibility of the nursing service, regardless of 
the mechanism through which those personnel are providing services 
(that is, hospital employee, contract, lease, other agreement, or 
volunteer).
    (7) The hospital must have policies and procedures in place 
establishing which outpatient departments, if any, are not required 
under hospital policy to have a registered nurse present. The policies 
and procedures must:
    (i) Establish the criteria such outpatient departments must meet, 
taking into account the types of services delivered, the general level 
of acuity of patients served by the department, and the established 
standards of practice for the services delivered;
    (ii) Establish alternative staffing plans;
    (iii) Be approved by the medical staff;
    (iv) Be reviewed at least once every three years.
    (c) * * *
    (1) Drugs and biologicals must be prepared and administered in 
accordance with Federal and State laws, the orders of the practitioner 
or practitioners responsible for the patient's care, and accepted 
standards of practice.
* * * * *
    (3) With the exception of influenza and pneumococcal vaccines, 
which may be administered per physician-approved hospital policy after 
an assessment of contraindications, orders for drugs and biologicals 
must be documented and signed by a practitioner who is authorized to 
write orders in accordance with State law and hospital policy, and who 
is responsible for the care of the patient.
    (i) If verbal orders are used, they are to be used infrequently.
    (ii) When verbal orders are used, they must only be accepted by 
persons who are authorized to do so by hospital policy and procedures 
consistent with Federal and State law.
    (iii) Orders for drugs and biologicals may be documented and signed 
by other practitioners only if such practitioners are acting in 
accordance with State law,

[[Page 39477]]

including scope-of-practice laws, hospital policies, and medical staff 
bylaws, rules, and regulations.
* * * * *
0
5. Section 482.24 is amended by revising paragraphs (c) introductory 
text and (c)(4)(ii), (iv), (vi), (vii), and (viii) to read as follows:


Sec.  482.24  Condition of participation: Medical record services.

* * * * *
    (c) Standard: Content of record. The medical record must contain 
information to justify all admissions and continued hospitalizations, 
support the diagnoses, describe the patient's progress and responses to 
medications and services, and document all inpatient stays and 
outpatient visits to reflect all services provided to the patient.
* * * * *
    (4) * * *
    (ii) All diagnoses specific to each inpatient stay and outpatient 
visit.
* * * * *
    (iv) Documentation of complications, hospital-acquired conditions, 
healthcare-associated infections, and adverse reactions to drugs and 
anesthesia.
* * * * *
    (vi) All practitioners' progress notes and orders, nursing notes, 
reports of treatment, interventions, responses to interventions, 
medication records, radiology and laboratory reports, and vital signs 
and other information necessary to monitor the patient's condition and 
to reflect all services provided to the patient.
    (vii) Discharge and transfer summaries with outcomes of all 
hospitalizations, disposition of cases, and provisions for follow-up 
care for all inpatient and outpatient visits to reflect the scope of 
all services received by the patient.
    (viii) Final diagnoses with completion of medical records within 30 
days following all inpatient stays, and within 7 days following all 
outpatient visits.
0
6. Section 482.27 is amended by revising paragraph (b)(7) and removing 
paragraph (b)(11) to read as follows:


Sec.  482.27  Condition of participation: Laboratory services.

* * * * *
    (b) * * *
    (7) Timeframe for notification. For notifications resulting from 
donors tested on or after February 20, 2008 as set forth at 21 CFR 
610.46 and 610.47 the notification effort begins when the blood 
collecting establishment notifies the hospital that it received 
potentially HIV or HCV infectious blood and blood components. The 
hospital must make reasonable attempts to give notification over a 
period of 12 weeks unless--
    (i) The patient is located and notified; or
    (ii) The hospital is unable to locate the patient and documents in 
the patient's medical record the extenuating circumstances beyond the 
hospital's control that caused the notification timeframe to exceed 12 
weeks.
* * * * *
0
7. Section 482.42 is revised to read as follows:


Sec.  482.42  Condition of participation: Infection prevention and 
control and antibiotic stewardship programs.

    The hospital must have active hospital-wide programs for the 
surveillance, prevention, and control of HAIs and other infectious 
diseases, and for the optimization of antibiotic use through 
stewardship. The programs must demonstrate adherence to nationally 
recognized infection prevention and control guidelines, as well as best 
practices for improving antibiotic use, where applicable, for reducing 
the development and transmission of HAIs and antibiotic-resistant 
organisms. Infection prevention and control problems and antibiotic use 
issues identified in the programs must be addressed in collaboration 
with the hospital-wide quality assessment and performance improvement 
(QAPI) program.
    (a) Standard: Infection prevention and control program organization 
and policies. The hospital must ensure all of the following:
    (1) An individual (or individuals), who are qualified through 
education, training, experience, or certification in infection 
prevention and control, are appointed by the governing body as the 
infection preventionist(s)/infection control professional(s) 
responsible for the infection prevention and control program and that 
the appointment is based on the recommendations of medical staff 
leadership and nursing leadership.
    (2) The hospital infection prevention and control program, as 
documented in its policies and procedures, employs methods for 
preventing and controlling the transmission of infections within the 
hospital and between the hospital and other institutions and settings.
    (3) The infection prevention and control program includes 
surveillance, prevention, and control of HAIs, including maintaining a 
clean and sanitary environment to avoid sources and transmission of 
infection, and addresses any infection control issues identified by 
public health authorities.
    (4) The infection prevention and control program reflects the scope 
and complexity of the hospital services provided.
    (b) Standard: Antibiotic stewardship program organization and 
policies. The hospital must ensure all of the following:
    (1) An individual, who is qualified through education, training, or 
experience in infectious diseases and/or antibiotic stewardship, is 
appointed by the governing body as the leader of the antibiotic 
stewardship program and that the appointment is based on the 
recommendations of medical staff leadership and pharmacy leadership.
    (2) An active hospital-wide antibiotic stewardship program must:
    (i) Demonstrate coordination among all components of the hospital 
responsible for antibiotic use and resistance, including, but not 
limited to, the infection prevention and control program, the QAPI 
program, the medical staff, nursing services, and pharmacy services.
    (ii) Document the evidence-based use of antibiotics in all 
departments and services of the hospital.
    (iii) Demonstrate improvements, including sustained improvements, 
in proper antibiotic use, such as through reductions in CDI and 
antibiotic resistance in all departments and services of the hospital.
    (3) The antibiotic stewardship program adheres to nationally 
recognized guidelines, as well as best practices, for improving 
antibiotic use.
    (4) The antibiotic stewardship program reflects the scope and 
complexity of the hospital services provided.
    (c) Standard: Leadership responsibilities. (1) The governing body 
must ensure all of the following:
    (i) Systems are in place and operational for the tracking of all 
infection surveillance, prevention, and control, and antibiotic use 
activities, in order to demonstrate the implementation, success, and 
sustainability of such activities.
    (ii) All HAIs and other infectious diseases identified by the 
infection prevention and control program as well as antibiotic use 
issues identified by the antibiotic stewardship program are addressed 
in collaboration with hospital QAPI leadership.
    (2) The infection preventionist(s)/infection control 
professional(s) are responsible for:
    (i) The development and implementation of hospital-wide infection 
surveillance, prevention, and

[[Page 39478]]

control policies and procedures that adhere to nationally recognized 
guidelines.
    (ii) All documentation, written or electronic, of the infection 
prevention and control program and its surveillance, prevention, and 
control activities.
    (iii) Communication and collaboration with the hospital's QAPI 
program on infection prevention and control issues.
    (iv) Competency-based training and education of hospital personnel 
and staff, including medical staff, and, as applicable, personnel 
providing contracted services in the hospital, on the practical 
applications of infection prevention and control guidelines, policies, 
and procedures.
    (v) The prevention and control of HAIs, including auditing of 
adherence to infection prevention and control policies and procedures 
by hospital personnel.
    (vi) Communication and collaboration with the antibiotic 
stewardship program.
    (3) The leader of the antibiotic stewardship program is responsible 
for:
    (i) The development and implementation of a hospital-wide 
antibiotic stewardship program, based on nationally recognized 
guidelines, to monitor and improve the use of antibiotics.
    (ii) All documentation, written or electronic, of antibiotic 
stewardship program activities.
    (iii) Communication and collaboration with medical staff, nursing, 
and pharmacy leadership, as well as the hospital's infection prevention 
and control and QAPI programs, on antibiotic use issues.
    (iv) Competency-based training and education of hospital personnel 
and staff, including medical staff, and, as applicable, personnel 
providing contracted services in the hospital, on the practical 
applications of antibiotic stewardship guidelines, policies, and 
procedures.
0
8. Section 482.58 is amended by revising paragraph (b)(6) to read as 
follows:


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

* * * * *
    (b) * * *
    (6) Discharge summary (Sec.  483.20(l)).
* * * * *

PART 485--CONDITIONS OF PARTICIPATION: SPECIALIZED PROVIDERS

0
9. 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)).


Sec.  485.627  [Amended]

0
10. Section 485.627 is amended by removing paragraph (b)(1) and 
redesignating paragraphs (b)(2) and (3) as paragraphs (b)(1) and (2), 
respectively.
0
11. Section 485.631 is amended by adding paragraph (d) to read as 
follows:


Sec.  485.631  Condition of participation: Staffing and staff 
responsibilities.

* * * * *
    (d) Standard: Periodic review of clinical privileges and 
performance. The CAH requires that--
    (1) The quality and appropriateness of the diagnosis and treatment 
furnished by nurse practitioners, clinical nurse specialist, and 
physician assistants at the CAH are evaluated by a member of the CAH 
staff who is a doctor of medicine or osteopathy or by another doctor of 
medicine or osteopathy under contract with the CAH.
    (2) The quality and appropriateness of the diagnosis and treatment 
furnished by doctors of medicine or osteopathy at the CAH are evaluated 
by--
    (i) One hospital that is a member of the network, when applicable;
    (ii) One Quality Improvement Organization (QIO) or equivalent 
entity;
    (iii) One other appropriate and qualified entity identified in the 
State rural health care plan;
    (iv) In the case of distant-site physicians and practitioners 
providing telemedicine services to the CAH's patient under an agreement 
between the CAH and a distant-site hospital, the distant-site hospital; 
or
    (v) In the case of distant-site physicians and practitioners 
providing telemedicine services to the CAH's patients under a written 
agreement between the CAH and a distant-site telemedicine entity, one 
of the entities listed in paragraphs (d)(2)(i) through (iii) of this 
section.
    (3) The CAH staff consider the findings of the evaluation and make 
the necessary changes as specified in paragraphs (b) through (d) of 
this section.
0
12. Section 485.635 is amended by removing paragraph (a)(3)(vi), 
redesignating paragraph (a)(3)(vii) as paragraph (a)(3)(vi), revising 
newly designated paragraph (a)(3)(vi), and adding paragraph (g) to read 
as follows:


Sec.  485.635  Condition of participation: Provision of services.

    (a) * * *
    (3) * * *
    (vi) Procedures that ensure that the nutritional needs of 
inpatients are met in accordance with recognized dietary practices. All 
patient diets, including therapeutic diets, must be ordered by the 
practitioner responsible for the care of the patients or by a qualified 
dietitian or qualified nutrition professional as authorized by the 
medical staff in accordance with State law governing dietitians and 
nutrition professionals and that the requirement of Sec.  483.25(i) of 
this chapter is met with respect to inpatients receiving post CAH SNF 
care.
* * * * *
    (g) Standard: Non-discrimination. A CAH must meet the following 
requirements:
    (1) Not discriminate on the basis of race, color, religion, 
national origin, sex (including gender identity), sexual orientation, 
age, or disability.
    (2) Establish and implement a written policy prohibiting 
discrimination on the basis of race, color, religion, national origin, 
sex (including gender identity), sexual orientation, age, or 
disability.
    (3) Inform each patient (and/or support person, where appropriate), 
in a language he or she can understand, of his or her right to be free 
from discrimination against them and how to file a complaint if they 
encounter discrimination.
0
13. Add Sec.  485.640 to read as follows:


Sec.  485.640  Condition of participation: Infection prevention and 
control and antibiotic stewardship programs.

    The CAH must have active facility-wide programs, for the 
surveillance, prevention, and control of HAIs and other infectious 
diseases and for the optimization of antibiotic use through 
stewardship. The programs must demonstrate adherence to nationally 
recognized infection prevention and control guidelines, as well as best 
practices for improving antibiotic use, where applicable, for reducing 
the development and transmission of HAIs and antibiotic-resistant 
organisms. Infection prevention and control problems and antibiotic use 
issues identified in the programs must be addressed in coordination 
with the facility-wide quality assessment and performance improvement 
(QAPI) program.
    (a) Standard: Infection prevention and control program organization 
and policies. The CAH must ensure all of the following:
    (1) An individual (or individuals), who are qualified through 
education, training, experience, or certification in infection 
prevention and control, are appointed by the governing body, or 
responsible individual, as the infection preventionist(s)/infection 
control professional(s) responsible for the

[[Page 39479]]

infection prevention and control program and that the appointment is 
based on the recommendations of medical staff leadership and nursing 
leadership.
    (2) The infection prevention and control program, as documented in 
its policies and procedures, employs methods for preventing and 
controlling the transmission of infections within the CAH and between 
the CAH and other healthcare settings.
    (3) The infection prevention and control includes surveillance, 
prevention, and control of HAIs, including maintaining a clean and 
sanitary environment to avoid sources and transmission of infection, 
and that the program also addresses any infection control issues 
identified by public health authorities.
    (4) The infection prevention and control program reflects the scope 
and complexity of the CAH services provided.
    (b) Standard: Antibiotic stewardship program organization and 
policies. The CAH must ensure that:
    (1) An individual, who is qualified through education, training, or 
experience in infectious diseases and/or antibiotic stewardship, is 
appointed by the governing body, or responsible individual, as the 
leader of the antibiotic stewardship program and that the appointment 
is based on the recommendations of medical staff leadership and 
pharmacy leadership.
    (2) An active facility-wide antibiotic stewardship program must:
    (i) Demonstrate coordination among all components of the CAH 
responsible for antibiotic use and resistance, including, but not 
limited to, the infection prevention and control program, the QAPI 
program, the medical staff, nursing services, and pharmacy services.
    (ii) Document the evidence-based use of antibiotics in all 
departments and services of the CAH.
    (iii) Demonstrate improvements, including sustained improvements, 
in proper antibiotic use, such as through reductions in CDI and 
antibiotic resistance in all departments and services of the CAH.
    (3) The antibiotic stewardship program adheres to nationally 
recognized guidelines, as well as best practices, for improving 
antibiotic use.
    (4) The antibiotic stewardship program reflects the scope and 
complexity of the CAH services provided.
    (c) Standard: Leadership responsibilities. (1) The governing body, 
or responsible individual, must ensure all of the following:
    (i) Systems are in place and operational for the tracking of all 
infection surveillance, prevention and control, and antibiotic use 
activities, in order to demonstrate the implementation, success, and 
sustainability of such activities.
    (ii) All HAIs and other infectious diseases identified by the 
infection prevention and control program as well as antibiotic use 
issues identified by the antibiotic stewardship program are addressed 
in collaboration with the CAH's QAPI leadership.
    (2) The infection prevention and control professional(s) are 
responsible for:
    (i) The development and implementation of facility-wide infection 
surveillance, prevention, and control policies and procedures that 
adhere to nationally recognized guidelines.
    (ii) All documentation, written or electronic, of the infection 
prevention and control program and its surveillance, prevention, and 
control activities.
    (iii) Communication and collaboration with the CAH's QAPI program 
on infection prevention and control issues.
    (iv) Competency-based training and education of CAH personnel and 
staff, including medical staff, and, as applicable, personnel providing 
contracted services in the CAH, on the practical applications of 
infection prevention and control guidelines, policies and procedures.
    (v) The prevention and control of HAIs, including auditing of 
adherence to infection prevention and control policies and procedures 
by CAH personnel.
    (vi) Communication and collaboration with the antibiotic 
stewardship program.
    (3) The leader of the antibiotic stewardship program is responsible 
for:
    (i) The development and implementation of a facility-wide 
antibiotic stewardship program, based on nationally recognized 
guidelines, to monitor and improve the use of antibiotics.
    (ii) All documentation, written or electronic, of antibiotic 
stewardship program activities.
    (iii) Communication and collaboration with medical staff, nursing, 
and pharmacy leadership, as well as the CAH's infection prevention and 
control and QAPI programs, on antibiotic use issues.
    (iv) Competency-based training and education of CAH personnel and 
staff, including medical staff, and, as applicable, personnel providing 
contracted services in the CAHs, on the practical applications of 
antibiotic stewardship guidelines, policies, and procedures.
0
14. Section 485.641 is revised to read as follows:


Sec.  485.641  Condition of participation: Quality assessment and 
performance improvement program.

    The CAH must develop, implement, and maintain an effective, 
ongoing, CAH-wide, data-driven quality assessment and performance 
improvement (QAPI) program. The CAH must maintain and demonstrate 
evidence of the effectiveness of its QAPI program.
    (a) Definitions. For the purposes of this section:
    Adverse event means an untoward, undesirable, and usually 
unanticipated event that causes death or serious injury or the risk 
thereof.
    Error means the failure of a planned action to be completed as 
intended or the use of a wrong plan to achieve an aim. Errors can 
include problems in practice, products, procedures, and systems; and
    Medical error means an error that occurs in the delivery of 
healthcare services.
    (b) Standard: QAPI program design and scope. The CAH's QAPI program 
must:
    (1) Be appropriate for the complexity of the CAH's organization and 
services provided.
    (2) Be ongoing and comprehensive.
    (3) Involve all departments of the CAH and services (including 
those services furnished under contract or arrangement).
    (4) Use objective measures to evaluate its organizational 
processes, functions and services.
    (5) Address outcome indicators related to improved health outcomes 
and the prevention and reduction of medical errors, adverse events, 
CAH-acquired conditions, and transitions of care, including 
readmissions.
    (c) Standard: Governance and leadership. The CAH's governing body 
or responsible individual is ultimately responsible for the CAH's QAPI 
program and is responsible and accountable for ensuring that the QAPI 
program meets the requirements of paragraph (b) of this section and 
that:
    (1) Clear expectations for safety are communicated, implemented, 
and followed throughout the CAH.
    (2) The QAPI efforts address priorities for improved quality of 
care and patient safety.
    (3) All improvement actions are evaluated and modified as needed.
    (4) Adequate resources are allocated for measuring, assessing, 
improving,

[[Page 39480]]

and sustaining the CAH's performance and reducing risk to patients.
    (5) The determination of the number of distinct improvement 
projects is made annually.
    (6) The CAH develops and implements policies and procedures for 
QAPI that address what actions the CAH staff should take to prevent and 
report unsafe patient care practices, medical errors, and adverse 
events.
    (d) Standard: Program activities. For each of the areas listed in 
paragraph (b) and (c) of this section, the CAH must:
    (1) Focus on measures related to improved health outcomes that are 
shown to be predictive of desired patient outcomes.
    (2) Use the measures to analyze and track its performance.
    (3) Set priorities for performance improvement, considering either 
high-volume, high-risk services, or problem-prone areas.
    (e) Performance improvement projects. As part of its QAPI program, 
the CAH must:
    (1) Conduct performance improvement projects. The number and scope 
of the distinct improvement projects conducted must be proportional to 
the scope and complexity of the CAH's services and operations.
    (2) The CAH maintains and demonstrates written or electronic 
evidence and documentation of its QAPI projects.
    (f) Standard: Program data collection and analysis. (1) The program 
must incorporate quality indicator data including patient care data, 
and other relevant data, such as data submitted to or received from 
national quality reporting and quality performance programs including 
but not limited to data related to hospital readmissions and hospital-
acquired conditions.
    (2) The CAH must use the data collected to:
    (i) Monitor the effectiveness and safety of services provided and 
quality of care.
    (ii) Identify opportunities for improvement and changes that will 
lead to improvement.
    (3) The frequency and detail of data collection must be approved by 
the CAH's governing body or responsible individual.
0
15. Section 485.645 is amended by revising the introductory text to 
read as follows:


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

    A CAH must meet the following requirements in order to be granted 
an approval from CMS to provide post-CAH SNF care, as specified in 
Sec.  409.30 of this chapter, and to be paid for SNF-level services, in 
accordance with paragraph (c) of this section.
* * * * *

    Dated: January 28, 2016.
Andrew M. Slavitt,
Acting Administrator, Centers for Medicare & Medicaid Services.
    Dated: May 11, 2016.
Sylvia M. Burwell,
Secretary, Department of Health and Human Services.
[FR Doc. 2016-13925 Filed 6-13-16; 4:15 pm]
BILLING CODE 4120-01-P