Medicare and Medicaid Programs; Hospital and Critical Access Hospital (CAH) Changes To Promote Innovation, Flexibility, and Improvement in Patient Care, 39447-39480 [2016-13925]

Download as PDF Vol. 81 Thursday, No. 116 June 16, 2016 Part IV Department of Health and Human Services asabaliauskas on DSK3SPTVN1PROD with PROPOSALS Centers for Medicare & Medicaid Services 42 CFR Parts 482 and 485 Medicare and Medicaid Programs; Hospital and Critical Access Hospital (CAH) Changes To Promote Innovation, Flexibility, and Improvement in Patient Care; Proposed Rule VerDate Sep<11>2014 19:01 Jun 15, 2016 Jkt 238001 PO 00000 Frm 00001 Fmt 4717 Sfmt 4717 E:\FR\FM\16JNP3.SGM 16JNP3 39448 Federal Register / Vol. 81, No. 116 / Thursday, June 16, 2016 / Proposed Rules 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 Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Proposed rule. AGENCY: 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 https://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 asabaliauskas on DSK3SPTVN1PROD with PROPOSALS SUMMARY: VerDate Sep<11>2014 19:01 Jun 15, 2016 Jkt 238001 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, AlphaBanu 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: https:// 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. PO 00000 Frm 00002 Fmt 4701 Sfmt 4702 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 E:\FR\FM\16JNP3.SGM 16JNP3 Federal Register / Vol. 81, No. 116 / Thursday, June 16, 2016 / Proposed Rules 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 asabaliauskas on DSK3SPTVN1PROD with PROPOSALS 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 hospitalacquired conditions (HACs), including reduced incidence of healthcareassociated 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 VerDate Sep<11>2014 19:01 Jun 15, 2016 Jkt 238001 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 sevenstate 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, PO 00000 Frm 00003 Fmt 4701 Sfmt 4702 39449 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 healthcareassociated 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 AntibioticResistant Bacteria (CARB); and the Department’s National Quality Strategy (https://www.ahrq.gov/ workingforquality/). The National Action Plan for Combating E:\FR\FM\16JNP3.SGM 16JNP3 39450 Federal Register / Vol. 81, No. 116 / Thursday, June 16, 2016 / Proposed Rules Antibiotic-Resistant Bacteria, which was developed by the interagency Task Force for Combating AntibioticResistant 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-obamaadministration-releases-national-actionplan-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 (https://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. asabaliauskas on DSK3SPTVN1PROD with PROPOSALS II. Provisions of the Proposed Rule A. Patient’s Rights (§ 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 VerDate Sep<11>2014 19:01 Jun 15, 2016 Jkt 238001 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 PO 00000 Frm 00004 Fmt 4701 Sfmt 4702 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 AfricanAmerican 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 E:\FR\FM\16JNP3.SGM 16JNP3 Federal Register / Vol. 81, No. 116 / Thursday, June 16, 2016 / Proposed Rules asabaliauskas on DSK3SPTVN1PROD with PROPOSALS 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 § 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 § 482.13, one commenter requested that CMS make a clarifying VerDate Sep<11>2014 19:01 Jun 15, 2016 Jkt 238001 statement regarding the requirements at § 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 § 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 ‘physiciandependent’ 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 physiciandelegated authority would establish that the PA was not independently authorized by State law and hospital PO 00000 Frm 00005 Fmt 4701 Sfmt 4702 39451 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 § 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 § 482.13(e)(5), as well as at § 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 § 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 § 482.13(e)(8)(ii) would state that, after 24 hours, before writing E:\FR\FM\16JNP3.SGM 16JNP3 39452 Federal Register / Vol. 81, No. 116 / Thursday, June 16, 2016 / Proposed Rules asabaliauskas on DSK3SPTVN1PROD with PROPOSALS 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 § 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 § 482.13(d) (71 FR 71426). Specifically, § 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 VerDate Sep<11>2014 19:01 Jun 15, 2016 Jkt 238001 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 § 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.’’ (https:// 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: https:// www.hhs.gov/hipaa/filing-a-complaint/ index.html. B. Quality Assessment and Performance Improvement (QAPI) Program (§ 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 PO 00000 Frm 00006 Fmt 4701 Sfmt 4702 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 § 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 E:\FR\FM\16JNP3.SGM 16JNP3 Federal Register / Vol. 81, No. 116 / Thursday, June 16, 2016 / Proposed Rules asabaliauskas on DSK3SPTVN1PROD with PROPOSALS 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 (§ 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 § 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 § 482.23(b)(7). We propose to allow a hospital to establish a policy that would specify which, if any, outpatient VerDate Sep<11>2014 19:01 Jun 15, 2016 Jkt 238001 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 PO 00000 Frm 00007 Fmt 4701 Sfmt 4702 39453 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 § 482.12(c) that are currently in paragraphs (c)(1) and (3). We discuss these technical corrections in detail below. D. Medical Record Services (§ 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 (§ 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 § 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 E:\FR\FM\16JNP3.SGM 16JNP3 asabaliauskas on DSK3SPTVN1PROD with PROPOSALS 39454 Federal Register / Vol. 81, No. 116 / Thursday, June 16, 2016 / Proposed Rules 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 § 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 § 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 § 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 § 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 VerDate Sep<11>2014 19:01 Jun 15, 2016 Jkt 238001 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 § 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 (§ 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. PO 00000 Frm 00008 Fmt 4701 Sfmt 4702 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 https:// www.hhs.gov/ash/initiatives/hai/ actionplan/.) 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 § 482.42 in an effort to further clarify existing requirements and update regulatory language to reflect state-ofthe-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 § 482.42 In its present form, the ‘‘Infection Control’’ CoP set forth at § 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 E:\FR\FM\16JNP3.SGM 16JNP3 asabaliauskas on DSK3SPTVN1PROD with PROPOSALS Federal Register / Vol. 81, No. 116 / Thursday, June 16, 2016 / Proposed Rules 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 antibioticresistant 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, https://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— VerDate Sep<11>2014 19:01 Jun 15, 2016 Jkt 238001 Survey Protocol, Regulations and Interpretive Guidelines for Hospitals, pp.361–362, https://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 § 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 PO 00000 Frm 00009 Fmt 4701 Sfmt 4702 39455 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. § 482.42(a) Standard: Infection Prevention and Control Program Organization and Policies We propose substantive changes to § 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 § 482.42(a) and some would be moved to § 482.42(c)(2). § 482.42(a)(1) Infection Control Officer(s) Specifically, at § 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 E:\FR\FM\16JNP3.SGM 16JNP3 asabaliauskas on DSK3SPTVN1PROD with PROPOSALS 39456 Federal Register / Vol. 81, No. 116 / Thursday, June 16, 2016 / Proposed Rules 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 § 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 highlevel 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 VerDate Sep<11>2014 19:01 Jun 15, 2016 Jkt 238001 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. § 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 § 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 https://www.cdc.gov/ HAI/settings/outpatient/outpatient-careguidelines.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 communityonset 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 PO 00000 Frm 00010 Fmt 4701 Sfmt 4702 hospital’s inpatient and outpatient locations. § 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 HealthcareAssociated Infections as a resource for identifying prominent HAIs. (HHS. ‘‘HHS Action Plan to Prevent Healthcare-Associated Infections.’’ Accessed 3 August 2011 https:// www.hhs.gov/ash/initiatives/hai/ actionplan/). 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. § 482.42(a)(4) Scope and Complexity We also propose to add a requirement at § 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. E:\FR\FM\16JNP3.SGM 16JNP3 asabaliauskas on DSK3SPTVN1PROD with PROPOSALS Federal Register / Vol. 81, No. 116 / Thursday, June 16, 2016 / Proposed Rules § 482.42(b) Standard: Antibiotic Stewardship Program Organization and Policies We propose a new standard at § 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 hospitalwide 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 VerDate Sep<11>2014 19:01 Jun 15, 2016 Jkt 238001 ample opportunity to improve use and patient safety by reducing incorrect and inappropriate antibiotic prescribing (https://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 (https://www.cdc.gov/ vitalsigns/antibiotic-prescribingpractices/; https:// 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.’’ (https://www.sheaonline.org/View/ArticleId/265/SHEAIDSA-letter-to-CMS-advancingAntimicrobial-Stewardship-as-aCondition-of-Participation.aspx) PO 00000 Frm 00011 Fmt 4701 Sfmt 4702 39457 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 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. § 482.42(b)(1) Leader of the Antibiotic Stewardship Program We propose a new provision at § 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 1 ‘‘Antimicrobial Agent Use’’. https:// www.idsociety.org/Antimicrobial_Agents/. ‘‘Antimicrobial Stewardship: Guidelines’’. https:// www.shea-online.org/PriorityTopics/ AntimicrobialStewardship/Guidelines.aspx. ‘‘Antimicrobial Stewardship Resources’’. https:// www.ashp.org/menu/PracticePolicy/ ResourceCenters/Inpatient-Care-Practitioners/ Antimicrobial-Stewardship. ‘‘Core Elements of Hospital Antibiotic Stewardship Programs’’ https:// www.cdc.gov/getsmart/healthcare/implementation/ core-elements.html. E:\FR\FM\16JNP3.SGM 16JNP3 39458 Federal Register / Vol. 81, No. 116 / Thursday, June 16, 2016 / Proposed Rules 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. § 482.42(b)(2)(i), (ii), and (iii) Meeting the Goals of the Antibiotic Stewardship Program Proposed requirements at § 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. asabaliauskas on DSK3SPTVN1PROD with PROPOSALS § 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 § 482.42(a)(4), the hospital also ensures that the AS program reflects the scope and complexity of services offered. § 482.42(c) Leadership Responsibilities We propose to revise the requirements currently at § 482.42(b), ‘‘Leadership responsibilities,’’ by proposing a new standard at § 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 VerDate Sep<11>2014 19:01 Jun 15, 2016 Jkt 238001 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. § 482.42(c)(1) The Governing Body We propose requirements at § 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. § 482.42(c)(1)(i) Governing Body Responsibilities In particular, we would require at § 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. § 482.42(c)(1)(ii) Governing Body Responsibilities (Cont.) We are proposing at § 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 PO 00000 Frm 00012 Fmt 4701 Sfmt 4702 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. § 482.42(c)(2) The Infection Preventionists/Infection Control Professionals At § 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. § 482.42(c)(2)(i) The Infection Preventionists’/Infection Control Professionals’ Responsibilities We propose to add a requirement at § 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 healthcareassociated 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 E:\FR\FM\16JNP3.SGM 16JNP3 Federal Register / Vol. 81, No. 116 / Thursday, June 16, 2016 / Proposed Rules 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. [LipitzSnyderman 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. asabaliauskas on DSK3SPTVN1PROD with PROPOSALS § 482.42(c)(2)(ii), (iii), (iv), (v), and (vi) The Infection Preventionists’/Infection Control Professionals’ Responsibilities (Cont.) At § 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 VerDate Sep<11>2014 19:01 Jun 15, 2016 Jkt 238001 maintaining pertinent information in a systematic fashion. At § 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 § 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 § 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 § 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 https:// www.hhs.gov/ash/initiatives/hai/ actionplan/.). At § 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. PO 00000 Frm 00013 Fmt 4701 Sfmt 4702 39459 § 482.42(c)(3) The Antibiotic Stewardship Program Leader’s Responsibilities Finally in this CoP, at § 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 § 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 § 482.27(b)(11), ‘‘Applicability’’ and the corresponding requirements set out at § 482.27(b)(7)(ii). Corrected Reference in § 482.58 In our review of the Hospital Conditions of Participation, we found an incorrect cross-reference at § 482.58(b)(6), which currently reads E:\FR\FM\16JNP3.SGM 16JNP3 39460 Federal Register / Vol. 81, No. 116 / Thursday, June 16, 2016 / Proposed Rules asabaliauskas on DSK3SPTVN1PROD with PROPOSALS ‘‘Discharge planning (§ 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 § 483.20(l). Therefore, we propose to correct the reference to read ‘‘Discharge summary (§ 483.20(l))’’. Removal of Inappropriate References to § 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 § 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 § 410.71, but only with respect to clinical psychologist services as defined in § 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 § 482.12(c) to Medicare patients. With the exception of a few provisions in the CoPs such as those directly related to § 482.12(c) described here, the VerDate Sep<11>2014 19:01 Jun 15, 2016 Jkt 238001 remainder of the CoPs apply to all patients, regardless of payment source, and not just Medicare beneficiaries. For example, the Nursing Services CoP, at § 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 § 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 § 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 § 482.12(c). Therefore, we propose to delete references to § 482.12(c) found in the following provisions: § 482.13(e)(5), (e)(8)(ii), (e)(14), and (g)(4)(ii) in the Patients’ Rights CoP; and § 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 (§ 485.627(b)) The CoP at § 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 § 485.627(b) requires the disclosure of names and addresses of the person(s) principally responsible for the operation and medical direction PO 00000 Frm 00014 Fmt 4701 Sfmt 4702 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 § 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 § 485.627(b)(1). 2. Periodic Review of Clinical Privileges and Performance (§ 485.631(d)(1) Through (2)) The current CoP at § 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 § 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 nonphysician practitioners. We are proposing to change the current CoP at § 485.641 to reflect the current QAPI format used in hospitals. As such, we propose to retain the requirements under paragraphs § 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 § 485.631. We are not changing these requirements and believe that they are still appropriate for the CAH regulations. Since the current CoP under § 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’’ (§ 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. E:\FR\FM\16JNP3.SGM 16JNP3 asabaliauskas on DSK3SPTVN1PROD with PROPOSALS Federal Register / Vol. 81, No. 116 / Thursday, June 16, 2016 / Proposed Rules 3. Provision of Services (§ 485.635(a)(3)(vii)) We currently require CAHs at § 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 § 483.25(i) is met with respect to inpatients receiving posthospital 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 (§ 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 teambased 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 VerDate Sep<11>2014 19:01 Jun 15, 2016 Jkt 238001 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 postordering 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 PO 00000 Frm 00015 Fmt 4701 Sfmt 4702 39461 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, costeffective, 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 § 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 § 483.25(i) is met with respect to inpatients receiving post hospital SNF care. Evidence shows that if CAHs choose to grant these specific E:\FR\FM\16JNP3.SGM 16JNP3 39462 Federal Register / Vol. 81, No. 116 / Thursday, June 16, 2016 / Proposed Rules asabaliauskas on DSK3SPTVN1PROD with PROPOSALS 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 (§ 485.635(g)) At § 485.635(g) we propose a new requirement regarding nondiscriminatory behavior. As discussed in this preamble at § 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 § 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 VerDate Sep<11>2014 19:01 Jun 15, 2016 Jkt 238001 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 (§ 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 § 485.635(a)(3)(vi) and at § 485.641(b)(2). The infection control requirements for CAHs have remained unchanged since 1997. We are proposing to remove the current requirements at §§ 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 § 482.42 the issues and concerns regarding infection control, healthcareassociated 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 PO 00000 Frm 00016 Fmt 4701 Sfmt 4702 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. § 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 § 485.640(a)(1) we propose that the CAH ensure that an individual (or individuals), who are qualified through E:\FR\FM\16JNP3.SGM 16JNP3 Federal Register / Vol. 81, No. 116 / Thursday, June 16, 2016 / Proposed Rules 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 § 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 § 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 (https://www.cdc.gov/hai/pdfs/ guidelines/Ambulatory-Care+Checklist_ 508_11_2015.pdf.) asabaliauskas on DSK3SPTVN1PROD with PROPOSALS § 485.640(a)(3) Healthcare-Associated Infections (HAIs) We propose at § 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. § 485.640(a)(4) Scope and Complexity We are proposing at § 485.640(a)(4) that the infection prevention and control program reflects the scope and VerDate Sep<11>2014 19:01 Jun 15, 2016 Jkt 238001 complexity of the services provided by the CAH. § 485.640(b)(1) Leader of the Antibiotic Stewardship Program We propose at § 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. § 485.640(b)(2)(i),(ii), and (iii) Goals of the Antibiotic Stewardship Program The proposed requirements at § 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. § 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. § 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 PO 00000 Frm 00017 Fmt 4701 Sfmt 4702 39463 prevention and control professionals be addressed in collaboration with CAH leadership. We therefore propose at § 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 § 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 § 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 E:\FR\FM\16JNP3.SGM 16JNP3 39464 Federal Register / Vol. 81, No. 116 / Thursday, June 16, 2016 / Proposed Rules asabaliauskas on DSK3SPTVN1PROD with PROPOSALS 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 (§ 485.641) Since May 26, 1993 (58 FR 30630), the ‘‘Periodic evaluation and quality assurance review’’ CoP (§ 485.641) has not been updated to reflect current industry standards that utilize the QAPI model (§ 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 § 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, VerDate Sep<11>2014 19:01 Jun 15, 2016 Jkt 238001 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 PO 00000 Frm 00018 Fmt 4701 Sfmt 4702 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. https:// www.iom.edu/Reports/2004/QualityThrough-Collaboration-The-Future-ofRural-Health.aspx#sthash.2zF6T8kE. 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 § 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 § 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 E:\FR\FM\16JNP3.SGM 16JNP3 Federal Register / Vol. 81, No. 116 / Thursday, June 16, 2016 / Proposed Rules new standard under the ‘‘Staffing and staff responsibilities’’ CoP at § 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 § 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 § 485.641 ‘‘Condition of participation: Quality assessment and performance improvement program.’’ At § 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. asabaliauskas on DSK3SPTVN1PROD with PROPOSALS § 485.641(a) Definitions We have proposed at paragraph § 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 § 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. § 485.641(b) QAPI Program Design and Scope At proposed § 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 VerDate Sep<11>2014 19:01 Jun 15, 2016 Jkt 238001 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, hospitalacquired conditions, and transitions of care, including readmissions. § 485.641(c) Governance and Leadership We propose at § 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 § 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. PO 00000 Frm 00019 Fmt 4701 Sfmt 4702 39465 485.641(d) Program Activities We propose at § 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 highvolume, high-risk services, or problemprone areas. Analyses would be expected to be conducted at regular intervals to enable the CAH to identify areas or opportunities for improvement. § 485.641(e) Performance Improvement Projects We propose at § 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. § 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 § 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 E:\FR\FM\16JNP3.SGM 16JNP3 39466 Federal Register / Vol. 81, No. 116 / Thursday, June 16, 2016 / Proposed Rules 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 § 485.645 by correcting the word ‘‘provided’’ to ‘‘provide’’ in the lead first sentence. asabaliauskas on DSK3SPTVN1PROD with PROPOSALS III. Collection of Information Requirements Under the Paperwork Reduction Act of 1995, we are required to provide 60day 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 (§ 482.13) Proposed § 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 VerDate Sep<11>2014 19:01 Jun 15, 2016 Jkt 238001 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 § 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 antidiscrimination 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 § 482.13(i). The total estimated annual burden associated with this requirement is 1,225 hours (4,900 hospitals × .25) at a cost of $83,300 (1,225 hours × $68 for a nurse’s hourly salary). B. ICRs Regarding Quality Assessment and Performance Improvement (§ 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 § 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 PO 00000 Frm 00020 Fmt 4701 Sfmt 4702 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 (§ 482.23) We propose to revise § 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 E:\FR\FM\16JNP3.SGM 16JNP3 asabaliauskas on DSK3SPTVN1PROD with PROPOSALS Federal Register / Vol. 81, No. 116 / Thursday, June 16, 2016 / Proposed Rules 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 TJCaccredited 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 TJCaccredited 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 § 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 https://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 × $68 for a nurse’s hourly salary + 3 hours × $174 for an administrator’s hourly salary + 3 hours × $187 for a physician’s hourly salary = $1,287). For all 1,000 non-TJCaccredited hospitals to comply with this requirement, we estimate a total onetime cost of approximately $1.3 million (1,000 hospitals × $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 × $68 for a nurse’s hourly salary + 1 hour × $174 for an administrator’s hourly salary + 1 hour × $187 for a physician’s hourly salary) × 1,000 hospitals). The burden associated with these requirements is captured in an VerDate Sep<11>2014 19:01 Jun 15, 2016 Jkt 238001 information collection request (0938– NEW). D. ICRs Regarding Medical Record Services (§ 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 § 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 § 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 § 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 § 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 § 482.24(c)(4)(vii) to require that all patient medical records must document discharge and transfer summaries with outcomes of all hospitalizations, PO 00000 Frm 00021 Fmt 4701 Sfmt 4702 39467 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 § 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 § 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 https://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 × $68 for a nurse’s hourly salary + 3 hours × $174 for an administrator’s hourly salary + 3 hours × $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 × $1,287). The burden associated with these requirements is captured in an information collection request (0938–NEW). E. ICRs Regarding Provision of Services (§ 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 E:\FR\FM\16JNP3.SGM 16JNP3 39468 Federal Register / Vol. 81, No. 116 / Thursday, June 16, 2016 / Proposed Rules asabaliauskas on DSK3SPTVN1PROD with PROPOSALS 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 https://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 § 485.635(g). The total estimated annual burden associated with this requirement is 332 hours (1,328 hospitals × .25) at a cost of $22,576 (332 hours × $68 for a nurse’s hourly salary). F. ICRs Regarding Condition of Participation: Quality Assessment and Performance Improvement Program (§ 485.641) Proposed § 485.641 would require CAHs to develop, implement, and maintain an effective, ongoing, CAHwide, 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 § 485.641(b) through (g). The current CAH CoPs at § 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 VerDate Sep<11>2014 19:01 Jun 15, 2016 Jkt 238001 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 § 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 TJCaccredited CAHs are already in compliance with the requirements in proposed § 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 § 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, midlevel 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 PO 00000 Frm 00022 Fmt 4701 Sfmt 4702 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 midlevel 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 § 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 × $98) + $380 for a mid-level practitioner (4 hours × $95) + $952 (14 hours × $68 for a nurse) + $64 for a clerical staff person (2 hours × $32). Therefore, for all 1,004 non TJCdeemed CAHs to comply with these requirements, it would require 25,100 burden hours (25 × 1,004 non TJCdeemed CAHs) at a cost of approximately $2 million ($1,975 for each CAH × 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 E:\FR\FM\16JNP3.SGM 16JNP3 39469 Federal Register / Vol. 81, No. 116 / Thursday, June 16, 2016 / Proposed Rules 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: OIRA_submission@omb.eop.gov. 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. asabaliauskas on DSK3SPTVN1PROD with PROPOSALS 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 healthcareassociated 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 AntibioticResistant Bacteria (CARB); and the Department’s National Quality Strategy (https://www.ahrq.gov/ workingforquality/). 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 (https://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 Issue Frequency Hospitals ................................................................................. • Patients’ rights (ICR) .................................................... Number of affected entities ................................................................ One-time ................................................ VerDate Sep<11>2014 19:01 Jun 15, 2016 Jkt 238001 PO 00000 Frm 00023 Fmt 4701 Sfmt 4702 E:\FR\FM\16JNP3.SGM 4,900 4,900 16JNP3 Likely savings (+) or costs (¥) to society ($ millions) 0.083(¥) 39470 Federal Register / Vol. 81, No. 116 / Thursday, June 16, 2016 / Proposed Rules TABLE 1—SECTION-BY-SECTION ECONOMIC IMPACT ESTIMATES—Continued Issue Number of affected entities Frequency • Nursing services (ICR) ................................................. • Nursing services (ICR) ................................................. • Medical record services (ICR) ..................................... Recurring Annually ................................. One-time ................................................ One-time ................................................ • Infection Prevention & Control and Antibiotic Stewardship (RIA). One-time ................................................ Recurring annually ................................. Recurring Annually ................................. ................................................................ One-time ................................................ Recurring annually ................................. Recurring annually ................................. One-time ................................................ Recurring Annually ................................. Recurring Annually ................................. ................................................................ ................................................................ ................................................................ CAHs • • • • ....................................................................................... Provision of services (ICR) .......................................... QAPI (ICR) ................................................................... Food and dietary (RIA) ................................................ Infection Prevention & Control and Antibiotic Stewardship (RIA). Sub-Total Savings ............................................................ Sub-Total Costs ............................................................... Overall Savings Net of Costs .......................................... 1,000 1,000 4,900 4,900 2,940 2,940 1,328 1,328 1,004 650 1,328 1,328 1,328 ........................ ........................ ........................ Likely savings (+) or costs (¥) to society ($ millions) 1.3(¥) 0.429(¥) 6.3(¥) 20(¥) >693 to 1,193(¥) 1,020(+) 0.023(¥) 2(¥) Not estimated 5(¥) 45(¥) 37(+) 1,057(+) >773 to 1,273(¥) <¥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. asabaliauskas on DSK3SPTVN1PROD with PROPOSALS 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 https://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 HHSwide 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 VerDate Sep<11>2014 19:01 Jun 15, 2016 Jkt 238001 wages and fringe benefits, at https:// www.bls.gov/bls/blswage.htm and https://www.bls.gov/ncs/ect/). Infection Control and Antibiotic Stewardship (Infection Prevention and Control § 482.42) Licensed Independent Practitioners (Patients’ Rights § 482.13) We propose to delete the modifying term ‘‘independent’’ from the CoP at § 482.13(e)(5), as well as at § 482.13(e)(8)(ii). Therefore, we are proposing that § 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 § 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 selfdestructive 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. 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 PO 00000 Frm 00024 Fmt 4701 Sfmt 4702 E:\FR\FM\16JNP3.SGM 16JNP3 Federal Register / Vol. 81, No. 116 / Thursday, June 16, 2016 / Proposed Rules asabaliauskas on DSK3SPTVN1PROD with PROPOSALS 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 antibioticresistant 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, https://cms.gov/manuals/ Downloads/som107ap_a_hospitals.pdf). Infection Prevention and Control Specifically, at § 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 VerDate Sep<11>2014 19:01 Jun 15, 2016 Jkt 238001 percent of all hospitals (https:// 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 × 40 hours = 2,080 hours) at $68 per hour. The cost per hospital would be $141,440 annually (2,080 hours × $68 = $141,440). The total cost for all non-TJC-accredited hospitals would be approximately $173 million annually (1,225 × $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 × 16 burden hours) + $1,088 ($68 an hour for a nurse × 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 × 4,900 hospitals = 156,800 burden hours) at a one-time cost of approximately $20 million PO 00000 Frm 00025 Fmt 4701 Sfmt 4702 39471 ($4,080 for each hospital × 4,900 hospitals = $19,992,000 estimated cost). Antibiotic Stewardship Similarly at § 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 programsa 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 × $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 E:\FR\FM\16JNP3.SGM 16JNP3 39472 Federal Register / Vol. 81, No. 116 / Thursday, June 16, 2016 / Proposed Rules asabaliauskas on DSK3SPTVN1PROD with PROPOSALS (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 readmitted 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 101,000reduction 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. 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 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). VerDate Sep<11>2014 19:01 Jun 15, 2016 Jkt 238001 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 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 × 0.10 × 2,000 hours per year = $37,400 for a physician) + ($113 × 0.25 × 2,000 hours per year = $56,500 for a clinical pharmacist) + ($70 per hour × 0.05 × 2,000 hour per year 3 We invite data that would allow for quantification of the rule’s impacts on HAIs other than CDI. PO 00000 Frm 00026 Fmt 4701 Sfmt 4702 = $7,000 for a network data analyst)). The total annual labor cost for 60 percent of hospitals ($100,900 × 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 § 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. E:\FR\FM\16JNP3.SGM 16JNP3 asabaliauskas on DSK3SPTVN1PROD with PROPOSALS Federal Register / Vol. 81, No. 116 / Thursday, June 16, 2016 / Proposed Rules 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, costeffective, 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 VerDate Sep<11>2014 19:01 Jun 15, 2016 Jkt 238001 report (https://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 × 0.50 hours of a physician’s/APRN’s/PA’s/ dietitian’s/nutrition professional’s time × $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 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 PO 00000 Frm 00027 Fmt 4701 Sfmt 4702 39473 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. § 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 × 16 burden hours = $2,292) + $1,088($68 an hour for a nurse × 16 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. E:\FR\FM\16JNP3.SGM 16JNP3 39474 Federal Register / Vol. 81, No. 116 / Thursday, June 16, 2016 / Proposed Rules asabaliauskas on DSK3SPTVN1PROD with PROPOSALS 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 × 1,300 CAHs = 41,600 burden hours) at a one-time cost of approximately $5 million ($4,080 for each CAH × 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 × 0.05 × 2,000 hours per year = $18,700 for a physician) + ($113 per hour × 0.10 × 2,000 hours per year = $22,600 for a clinical pharmacist) + ($70 per hour × 0.025 × 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 lessthan-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 VerDate Sep<11>2014 19:01 Jun 15, 2016 Jkt 238001 (× 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 × 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 × $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 PO 00000 Frm 00028 Fmt 4701 Sfmt 4702 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. E:\FR\FM\16JNP3.SGM 16JNP3 39475 Federal Register / Vol. 81, No. 116 / Thursday, June 16, 2016 / Proposed Rules 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 https:// 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 ................................................................................................. Monetized ($million/year) ........................................................................... Qualitative 1,057 1,057 2015 2015 7% 3% 2016–2020 2016–2020 Potential Reductions in morbidity and mortality for hospital and CAH patients Costs * Annualized ................................................................................................. Monetized ($million/year) ........................................................................... asabaliauskas on DSK3SPTVN1PROD with PROPOSALS F. Conclusion List of Subjects 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. 748 to 1,248 748 to 1,248 42 CFR Part 482 19:01 Jun 15, 2016 Jkt 238001 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 1. The authority citation for part 482 continues to read as follows: ■ PO 00000 Frm 00029 Fmt 4701 7% 3% 2016–2020 2016–2020 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: ■ Authority: Secs. 1102, 1871 and 1881 of the Social Security Act (42 U.S.C. 1302, 1395hh, and 1395rr), unless otherwise noted. VerDate Sep<11>2014 2015 2015 Sfmt 4702 § 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 E:\FR\FM\16JNP3.SGM 16JNP3 asabaliauskas on DSK3SPTVN1PROD with PROPOSALS 39476 Federal Register / Vol. 81, No. 116 / Thursday, June 16, 2016 / Proposed Rules 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 VerDate Sep<11>2014 19:01 Jun 15, 2016 Jkt 238001 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. ■ 3. Section 482.21 is amended by revising paragraph (b)(1) to read as follows: § 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. * * * * * ■ 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: § 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 PO 00000 Frm 00030 Fmt 4701 Sfmt 4702 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, E:\FR\FM\16JNP3.SGM 16JNP3 Federal Register / Vol. 81, No. 116 / Thursday, June 16, 2016 / Proposed Rules including scope-of-practice laws, hospital policies, and medical staff bylaws, rules, and regulations. * * * * * ■ 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: § 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. ■ 6. Section 482.27 is amended by revising paragraph (b)(7) and removing paragraph (b)(11) to read as follows: asabaliauskas on DSK3SPTVN1PROD with PROPOSALS * § 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 VerDate Sep<11>2014 19:01 Jun 15, 2016 Jkt 238001 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. * * * * * ■ 7. Section 482.42 is revised to read as follows: § 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 antibioticresistant 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 PO 00000 Frm 00031 Fmt 4701 Sfmt 4702 39477 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 E:\FR\FM\16JNP3.SGM 16JNP3 39478 Federal Register / Vol. 81, No. 116 / Thursday, June 16, 2016 / Proposed Rules 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. ■ 8. Section 482.58 is amended by revising paragraph (b)(6) to read as follows: asabaliauskas on DSK3SPTVN1PROD with PROPOSALS § 482.58 Special requirements for hospital providers of long-term care services (‘‘swing-beds’’). * * * * * (b) * * * (6) Discharge summary (§ 483.20(l)). * * * * * PART 485—CONDITIONS OF PARTICIPATION: SPECIALIZED PROVIDERS 9. The authority citation for part 485 continues to read as follows: ■ VerDate Sep<11>2014 19:01 Jun 15, 2016 Jkt 238001 Authority: Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395(hh)). § 485.627 [Amended] 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. ■ 11. Section 485.631 is amended by adding paragraph (d) to read as follows: ■ § 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. ■ 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: § 485.635 Condition of participation: Provision of services. (a) * * * (3) * * * (vi) Procedures that ensure that the nutritional needs of inpatients are met PO 00000 Frm 00032 Fmt 4701 Sfmt 4702 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 § 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. ■ 13. Add § 485.640 to read as follows: § 485.640 Condition of participation: Infection prevention and control and antibiotic stewardship programs. The CAH must have active facilitywide 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 E:\FR\FM\16JNP3.SGM 16JNP3 asabaliauskas on DSK3SPTVN1PROD with PROPOSALS Federal Register / Vol. 81, No. 116 / Thursday, June 16, 2016 / Proposed Rules 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: VerDate Sep<11>2014 19:01 Jun 15, 2016 Jkt 238001 (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 PO 00000 Frm 00033 Fmt 4701 Sfmt 4702 39479 practical applications of antibiotic stewardship guidelines, policies, and procedures. ■ 14. Section 485.641 is revised to read as follows: § 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, CAHacquired 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, E:\FR\FM\16JNP3.SGM 16JNP3 39480 Federal Register / Vol. 81, No. 116 / Thursday, June 16, 2016 / Proposed Rules asabaliauskas on DSK3SPTVN1PROD with PROPOSALS 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 highvolume, high-risk services, or problemprone areas. (e) Performance improvement projects. As part of its QAPI program, the CAH must: (1) Conduct performance improvement projects. The number and VerDate Sep<11>2014 19:01 Jun 15, 2016 Jkt 238001 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 PO 00000 Frm 00034 Fmt 4701 Sfmt 9990 CAH’s governing body or responsible individual. ■ 15. Section 485.645 is amended by revising the introductory text to read as follows: § 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 postCAH SNF care, as specified in § 409.30 of this chapter, and to be paid for SNFlevel 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 E:\FR\FM\16JNP3.SGM 16JNP3

Agencies

[Federal Register Volume 81, Number 116 (Thursday, June 16, 2016)]
[Proposed Rules]
[Pages 39447-39480]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-13925]

[[Page 39447]]

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 https://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: https://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 (https://www.ahrq.gov/workingforquality/).
The National Action Plan for Combating

[[Page 39450]]

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 (https://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

[[Page 39451]]

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.''
(https://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: https://www.hhs.gov/hipaa/filing-a-complaint/.

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 https://www.hhs.gov/ash/initiatives/hai/actionplan/.) 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, https://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,
https://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 https://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 https://www.hhs.gov/ash/initiatives/hai/actionplan/).
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 (https://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 (https://www.cdc.gov/vitalsigns/antibiotic-prescribing-practices/; https://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.''
(https://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''. https://www.idsociety.org/Antimicrobial_Agents/. ``Antimicrobial Stewardship: Guidelines''.
https://www.shea-online.org/PriorityTopics/AntimicrobialStewardship/Guidelines.aspx. ``Antimicrobial Stewardship Resources''. https://www.ashp.org/menu/PracticePolicy/ResourceCenters/Inpatient-Care-Practitioners/Antimicrobial-Stewardship. ``Core Elements of Hospital
Antibiotic Stewardship Programs'' https://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 https://www.hhs.gov/ash/initiatives/hai/actionplan/.).
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

[[Page 39462]]

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 (https://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. https://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 Check^TM. 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 https://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 https://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 https://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: OIRA_submission@omb.eop.gov.

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 (https://www.ahrq.gov/workingforquality/).
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 (https://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 https://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 https://www.bls.gov/bls/blswage.htm
and https://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, https://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 (https://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 (https://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 https://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

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