Source: https://www.federalregister.gov/documents/2011/10/24/2011-27175/medicare-and-medicaid-programs-reform-of-hospital-and-critical-access-hospital-conditions-of
Timestamp: 2019-06-20 23:24:31
Document Index: 19849352

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Federal Register :: Medicare and Medicaid Programs; Reform of Hospital and Critical Access Hospital Conditions of Participation
A Proposed Rule by the Centers for Medicare & Medicaid Services on 10/24/2011
65891-65908 (18 pages)
2011-27175
1. Governing Body (§ 482.12)
2. Patient's Rights (§ 482.13)
3. Medical Staff (§ 482.22)
4. Nursing Services (§ 482.23)
Medical Record Services (§ 482.24)
6. Infection Control (§ 482.42)
7. Outpatient Services (§ 482.54)
8. Transplant Center Process Requirements—Organ Recovery and Receipt (§ 482.92)
Definitions (§ 485.602) and Provision of Services (§ 485.635)
10. Pharmaceutical Services (§ 482.25) and Infection Control (§ 482.42)
11. Personnel Qualifications (§ 485.604)
12. Surgical Services (§ 485.639)
Medical Staff (§ 482.22)
Physical Environment (§ 482.41)
A. ICRs Regarding Condition of Participation: Patient's Rights (§ 482.13)
B. ICRs Regarding Condition of Participation: Nursing Services (§ 482.23)
C. ICRs Regarding Condition of Participation: Medical Record Services (§ 482.24)
D. ICRs Regarding Condition of Participation: Infection Control (§ 482.42)
E. ICRs Regarding Condition of Participation: Transplant Center Process Requirements—Organ Recovery and Receipt (§ 482.92)
Death Notices for Soft Restraints (Patient's Rights § 482.13)
Nursing Services Care Plan (§ 482.23)
Medical Record Services—Authentication and Standing Orders (§ 482.24)
Outpatient Services (§ 482.54)
Transplant Organ Recovery (§ 482.92)
Infection Control Log (§ 484.42)
CAH Provision of Services (§ 485.635)
https://www.federalregister.gov/d/2011-27175 https://www.federalregister.gov/d/2011-27175
Start Preamble Start Printed Page 65891
Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services.
AHA American Hospital Association
AOA American Osteopathic Association
APRN Advanced Practice Registered Nurse
BBA Balanced Budget Act
CAH Critical Access Hospital
CCN CMS Certification Number
CDC Centers for Disease Control and Prevention
CfC Condition for Coverage
CoP Condition of Participation
DNV Det Norske Veritas
EACH Essential Access Community Hospital
H&P History and Physical Examination
HAI Healthcare-Associated Infection
HFAP Healthcare Facilities Accreditation Program
MRHFP Medicare Rural Hospital Flexibility Program
OBRA Omnibus Budget Reconciliation Act
OPO Organ Procurement Organization
PA Physician Assistant
RPCH Rural Primary Care Hospital
5. Medical Record Services (§ 482.24)
8. Transplant Center Process Requirements—Organ Recovery and Receipt (§ 482.92)Start Printed Page 65892
9. Definitions (§ 485.602) and Provision of Services (§ 485.635)
In accordance with the President's Executive Order 13563, we are reviewing regulations in an effort to reduce burden, maximize patient safety, and reflect current industry standards. We have identified several priority areas in the CoPs for both hospitals (42 CFR part 482) and CAHs (42 CFR part 485) to update and revise. Our identification and prioritization of these areas was a result of outreach to hospital Start Printed Page 65893stakeholders, such as the American Hospital Association (AHA) and TJC; and internal discussions among various components at CMS. We believe that these proposed revisions may eliminate or significantly reduce those instances where the CoPs are duplicative, unnecessary, and/or burdensome.
We propose to revise the “Governing body” requirements as follows: The Governing body CoP (§ 482.12) states that the hospital must have an effective governing body that is legally responsible for the conduct of the hospital as an institution. We have interpreted the governing body CoP as requiring that each hospital facility have a separate governing body (http://www.cms.gov/​manuals/​downloads/​som107ap_​a_​hospitals.pdf).
Based on our experience with hospitals and the input provided by stakeholders through anecdotal evidence, we believe that hospitals in a multi-hospital system (defined here as those having more than one CMS Certification Number (CCN)) can be effectively governed by a single governing body. Thus, we propose to revise and clarify the governing body requirement to reflect current hospital organizational structure whereby multi-hospital systems have integrated their governing body functions to oversee care in a more efficient and effective manner. Specifically, we propose to revise § 482.12 to state that “There must be an effective governing body that is legally responsible for the conduct of the hospital.”
CMS is therefore proposing to modify the reporting requirements for hospitals when the circumstances of a patient's death involve only the use of soft two-point wrist restraints and no use of seclusion. At § 482.13(g)(4) we propose that hospitals would be required to notify CMS of the deaths described at § 482.13(g)(2) (soft two-point wrist restraints and no use of seclusion) within seven days after the date of death through a log or other system. We propose that the record would include, at a minimum, the patient's name, date of birth, date of death, attending physician, primary diagnosis(es), and medical record number. We propose that hospitals make the log or other system accessible to CMS upon request at all times. We are unable to eliminate the reporting requirement for these deaths due to statutory provisions in the Children's Health Act that require such deaths to be reported.
We are proposing to introduce a measure of flexibility to these requirements and redesignate them at § 482.13(g)(1), by providing additional reporting options, as determined by CMS, which would include the use of facsimile, as well as an option for electronic reporting. In the event that electronic reporting technology develops more rapidly than the requirements for this section, we have proposed the term “electronically” rather than “email” to build in a small measure of flexibility.
The CMS condition of participation on “Medical Staff,” at § 482.22, concerns the organization and accountability of the hospital medical staff. CMS first adopted the term “medical staff” in 1986 when it began using the term at § 482.22 in place of “physicians,” to allow hospitals maximum flexibility in the granting of privileges and the organization of their professional staff (51 FR 22010). These changes were introduced to reflect the trend of extending patient care responsibilities to practitioners other than doctors of medicine or osteopathy. CMS has more recently modernized its approach to medical staff requirements with respect to telemedicine services through the rule “Medicare and Medicaid Programs: Changes Affecting Hospital and Critical Access Hospital Conditions of Participation: Telemedicine Credentialing and Privileging,” that became effective July 5, 2011 (76 FR 25563).
First, we propose to redesignate § 482.22(a)(2) to § 482.22(a)(5) and revise it by adding language to clarify that a hospital may grant privileges to both physicians and non-physicians to practice within their State scope of practice, regardless of whether they are also appointed to the hospital's medical staff. That is, technical membership in a hospital's medical staff would not be a prerequisite for a hospital's governing body to grant practice privileges to practitioners.
Hospitals wishing to bring on additional practitioners without also making them members of the medical staff would follow the same requirements specified in current regulation. That is, the medical staff would examine the credentials of each candidate and make recommendations to the governing body. Medical staff conducting the evaluations would operate under their own hospitals' Start Printed Page 65894policies and procedures. Moreover, the medical staff would continue to be limited by State law, and thus would not be permitted to grant a practitioner candidate any privileges beyond those allowed in the State where the hospital is located, where he or she would ultimately practice.
The second area we propose to address relates to the general management and oversight of practitioners. Prior to the beginning of this rulemaking process, we received questions from some hospitals about the appropriate credentialing and privileging process for APRNs. We believe the changes we are proposing at § 482.22(a)(5) would address them. For example, some hospitals have questioned whether APRNs should be managed by the human resources department, as most registered nurses are, or by the medical staff, as most PAs are. We believe that, to the extent allowed under their States' law, most hospitals already manage and oversee the services of APRNs through their medical staffs. In fact, technically, our current regulations already allow hospitals to appoint non-physician practitioners as members of their medical staffs, if the State law in which their hospital operates permits it. However, the numerous questions we have received in this area indicate that our current regulation is unclear. Therefore, we are proposing language to revise the section by clarifying that being a member of a hospital's medical staff is not a prerequisite to being granted privileges in the hospital, regardless of whether a practitioner is a physician or a non-physician.
One of our chief concerns, in the context of proposing this change, is to ensure that all practitioners working at a hospital would continue to follow the rules set forth for “Medical Staff” at § 482.22. Thus, we are proposing language within this provision that would require those physicians and non-physicians, who have been granted practice privileges within their scope of practice but without appointment to the medical staff, to be subject to the requirements contained within this section. That is, they would be subject to the same hospital requirements, medical staff bylaws, and medical staff oversight as outlined under this CoP and to which appointed medical staff members are also subject. Alternatively, a hospital could establish categories within its medical staff to create distinctions between practitioners who have full membership and a new category for those who could be classified as having an “associate,” “special,” or “limited” membership. Such a structure is neither required nor suggested; we are providing it here as an example of one possible way for a hospital to align all of its practitioners under the “Medical Staff” rules.
The third area in which we are proposing changes concerns the more direct responsibilities for the organization and accountability of the medical staff. These requirements are set forth at § 482.22(b)(3). Presently, the hospital may assign these management tasks to either an individual doctor of medicine or osteopathy or, when permitted by State law of the State in which the hospital is located, a doctor of dental surgery or dental medicine. CMS proposes to expand the list to include doctors of podiatric medicine (DPMs). We believe this change would permit a podiatric physician to serve as the president, or its equivalent, of a hospital's medical staff in a significant number of states. CMS is aware that in such states, the laws underscore the widely held conclusion that the education, training, and experience of podiatric physicians are similar to that of their allopathic and osteopathic colleagues with respect to serving in such a hospital leadership position. With this proposed change, CMS wishes to ensure its hospital leadership requirements are not in conflict with State laws that would otherwise allow podiatric physicians to serve in this capacity. Moreover, CMS recognizes that the act of being selected as the president of the medical staff reflects the high level of confidence in which a candidate is held by his or her peers.
We propose to revise the hospital nursing service requirements at § 482.23 (b)(4), “Nursing services,” which currently requires a hospital to ensure that the nursing staff develop, and keep current, a nursing care plan for each patient. We propose that for those hospitals that use an interdisciplinary plan of care in providing patient care, the care plan for nursing services be developed and kept current as part of the hospital's overall interdisciplinary care plan.
An interdisciplinary care plan optimizes the involvement of the various healthcare disciplines (such as nursing, respiratory care, occupational therapy, and pharmacy) to identify and document patient treatment goals and objectives, interventions, and progress in meeting those goals and objectives. We propose to revise our requirements to be less burdensome and more in line with current practice by proposing that, for those hospitals that use an interdisciplinary care plan, the nursing services care plan could be integrated into the overall hospital interdisciplinary care plan. This would decrease the burden of the nursing staff having to develop two care plans, one to fulfill the nursing services requirement and the other to fulfill the particular hospital's requirement for an Start Printed Page 65895interdisciplinary care plan, and would improve the quality of patient care by the effective and timely communication of information pertaining to the nursing care of the patient.
We propose to revise the current Nursing services CoP at § 482.23(c) by adding new provisions that would allow for drugs and biologicals to be prepared and administered on the orders of practitioners other than those specified under § 482.12(c). We are also proposing a further revision to § 482.23(c) that would add a new provision allowing orders for drugs and biologicals to be documented and signed by practitioners other than those specified under § 482.12(c). We would allow for these two revisions only if such practitioners are acting in accordance with State law, including scope of practice laws, and only if the hospital has granted them privileges to do so.
Within this section of the Nursing services CoP, we are also proposing changes that would allow hospitals to use standing orders. At § 482.23(c)(1)(ii), we propose to allow for the preparation and administration of drugs and biologicals on the orders contained within pre-printed and electronic standing orders, order sets, and protocols for patient orders, but only if such orders meet the requirements of § 482.24(c)(3), as discussed below.
Much of the evidence on the effectiveness of hospital standing orders is in the context of their use by Rapid Response Teams (RRTs) and then only when applied in a very limited and focused manner. A search of the medical literature revealed that there may be additional areas where standing orders have some efficacy in the hospital setting. (http://www.innovations.ahrq.gov/​content.aspx?​id=​1750;​ http://www.cdc.gov/​mmwr/​PDF/​rr/​rr5416.pdf).
We propose to eliminate the requirement, currently at § 482.23(c)(3), that non-physicians must have special training in administering blood transfusions and intravenous medications. We believe that this training is standard practice, and thus does not need to be prescribed in these regulations.
At § 482.23(c)(4) we propose that those who administer blood transfusions and intravenous medications do so in accordance with State law and approved medical staff policies and procedures. We propose to retain § 482.23(c)(4) and redesignate it at § 482.23(c)(5), without any content change.
We also propose additional revisions at proposed § 482.23(c)(6) that would allow hospitals the flexibility to develop and implement policies and procedures for a patient and his or her caregivers/support persons to administer specific medications (non-controlled drugs and biologicals).This proposal would be consistent with the current practice of giving patients access at the bedside to urgently needed medications, such as nitroglycerine tablets and inhalers, and selected non-prescription medications, such as lotions and rewetting eye drops. These proposed changes would apply to the self-administration of both hospital-issued medications and the patient's own medications brought into the hospital.
On November 27, 2006, CMS published a final rule that made revisions to specific provisions of the hospital CoPs at 42 CFR part 482 (71 FR 68694). The current requirements, as finalized at § 482.24(c)(1)(i) in the 2006 rule, specify that all orders, including verbal orders, must be dated, timed, and authenticated promptly by the ordering practitioner. Also included in the rule was an exception to this requirement at § 482.24(c)(1)(ii), which allows, for the 5 year period following January 26, 2007, all orders, including verbal orders, to be dated, timed, and authenticated by the ordering practitioner or another practitioner who is responsible for the care of the patient as specified under Start Printed Page 65896§ 482.12(c) and who is authorized to write orders by hospital policy in accordance with State law. When the rule was published in late 2006, the 5-year sunset provision was included with the thought that such an exception would not be needed five years hence since various technologies (for example, computerized physician order entry and authentication from a distance through a telecommunication medium) would have evolved and proliferated to the extent where in-person authentication by a practitioner would no longer be common or necessary. Though technologies have certainly advanced in the five years since publication of the rule, there is still not universal application and use of these advancements in hospitals or among practitioners.
Additionally, § 482.24(c)(1)(iii) establishes that all verbal orders must be authenticated based upon Federal and State law; in the absence of a State law designating a specific timeframe for the authentication of verbal orders, this provision then specifies that all verbal orders must be authenticated within 48 hours. Many stakeholders in the hospital community, including The Joint Commission and the American Hospital Association, have pointed out to us that this requirement is not only a particularly burdensome one for hospitals, but also one that does not have any appreciable benefit for patients with regard to safe care. We are proposing to consolidate three existing provisions into one new provision at § 482.24(c)(2). Specifically, we would remove existing paragraphs (c)(1)(i) through (c)(1)(iii) and add a new § 482.24(c)(2). Existing paragraph (c)(2) would be redesignated as (c)(3). This new provision would retain the requirement that all orders, including verbal orders, must be dated, timed, and authenticated promptly by the ordering practitioner, but would add the exception currently contained at § 482.24(c)(1)(ii) by allowing for authentication by either the ordering practitioner or “another practitioner who is responsible for the care of the patient as specified under § 482.12(c) and authorized to write orders by hospital policy in accordance with State law.” In this way we would remove the sunset provision and the 48-hour timeframe requirement for authentication of orders and instead defer to hospital policy and State law for establishment of any timeframe. If there was no State law establishing such a timeframe, then a hospital would be allowed to establish their own timeframe for authentication of orders, including verbal orders.
Due to the risk of error involved in the use of verbal orders, we encourage hospitals to keep the use of such orders to a minimum and to establish policies that discourage their use. When verbal orders must be used, hospitals should have their own policies in place (e.g., “read-back and verify” requirements) to ensure accuracy in the transcribing of orders, particularly those involving medication dosages.
As discussed above in the Nursing services CoP section, we are proposing changes to that CoP as well as to the Medical records services CoP that would allow hospitals to use standing orders as long as certain provisions were met. In this rule, we propose new provisions to § 482.24(c)(3) that would allow a hospital to use pre-printed and electronic standing orders, order sets, and protocols for patient orders only if the hospital: (1) Establishes that such orders and protocols have been reviewed and approved by the medical staff in consultation with the hospital's nursing and pharmacy leadership; (2) demonstrates that such orders and protocols are consistent with nationally recognized and evidence-based guidelines; (3) ensures that the periodic and regular review of such orders and protocols is conducted by the medical staff, in consultation with the hospital's nursing and pharmacy leadership, to determine the continuing usefulness and safety of the orders and protocols; and (4) ensures that such orders and protocols are dated, timed, and authenticated promptly in the patient's medical record by the ordering practitioner or another practitioner responsible for the care of the patient as specified under § 482.12(c) and authorized to write orders by hospital policy in accordance with State law.
For additional guidance on the use of standing orders, stakeholders should review the CMS memorandum (CMS S&C-09-10) issued on October 24, 2008 (http://www.cms.gov/​SurveyCertificationGenInfo/​downloads/​SCLetter09-10.pdf), where we pointed out our strong support of the use of evidence-based protocols, developed by the medical staff and based on recognized standards of practice, that advance the quality of care provided to patients. CMS, through the CoPs, requires hospitals and practitioners to take a thoughtful and responsible approach when using pre-printed and electronic standing orders, order sets, and protocols, particularly those orders that may be initiated as part of an emergency response or as part of an evidence-based treatment regimen where it is not practicable for a nurse to obtain the order and authentication from the physician or practitioner prior to the provision of care. In all cases protocols and standing orders must be medically necessary for the patients to whom they are applied, and the treating physician must be able to modify, cancel, void or decline to authenticate orders that were not medically necessary in a particular situation. Under no circumstances should a hospital use standing orders in a manner that requires any staff not authorized to write patient orders to make clinical decisions outside of their scope of practice in order to initiate such orders. Hospital policies and procedures that discuss the use of standing orders should address well-defined clinical scenarios as a standard of practice for the use of such orders. We would expect the policies and procedures to also address the process by which a standing order is developed; approved; monitored; initiated by authorized staff; and subsequently authenticated by physicians or practitioners responsible for the care of the patient. Under the CoPs, all orders, whether written or verbal, must be authenticated and documented in the patient's medical record by a practitioner responsible for the care of the patient.
We would also expect to see specific criteria for a nurse or other authorized personnel to initiate the execution of a particular standing order clearly identified in the protocol for the order, for example, the specific clinical situations, patient conditions, or diagnoses by which initiation of the order would be justified. Policies and procedures should also address the instructions that the medical, nursing, and other applicable professional staff receive on the conditions and criteria for using standing orders as well as any individual staff responsibilities associated with the initiation and execution of standing orders. An order that has been initiated for a specific patient must be added to the patient's medical record at the time of initiation, or as soon as possible thereafter. Likewise, standing order policies and procedures must specify the process whereby the physician or other practitioner responsible for the care of the patient acknowledges and authenticates the initiation of all standing orders after the fact, with the exception of influenza and pneumococcal polysaccharide vaccines, which do not require such authentication in accordance with § 482.23(c)(2).Start Printed Page 65897
Since this requirement was published, advances in infection control surveillance systems have made the need for a separate infection log obsolete. We have also received complaints from stakeholders that the log requirement is too prescriptive and burdensome. We therefore propose to eliminate the current requirement at § 482.42(a)(2), proposing instead to allow hospitals flexibility in their approach to the tracking and surveillance of infections. The modern surveillance systems already in use include infection detection, data collection and analysis, monitoring, and evaluation of preventive interventions. These activities are already required at § 482.42(a)(1), which we propose to retain under § 482.42(a). Specifically, the infection control officer or officers are required to develop a system for identifying, reporting, investigating, and controlling infections and communicable diseases of patients and personnel. The requirements at § 482.42(a), together with modern surveillance practices, have made the requirement for a separate infection control log unnecessarily redundant and burdensome.
Under the CoPs, the provision of outpatient services is an optional hospital service. However, if a hospital provides outpatient services, the services must meet the needs of patients according to acceptable standards of practice as required at § 482.54. The current provision at § 482.54(b)(1) also requires the hospital to assign an individual to be responsible for outpatient services.
We are aware that increasingly more hospital services are offered as outpatient services today than when this particular CoP was first developed. As hospitals have expanded the outpatient services offered to patients, many hospitals have determined that it is in the best interests of patient safety and management practices to appoint more than one individual to oversee the various services offered and also to fully integrate their outpatient services with inpatient services. Additionally, these hospitals have realized that as they have expanded the variety of outpatient services offered, a single outpatient services leader may not possess the training and expertise to oversee the myriad services that the hospital is capable of providing in the outpatient setting. For example, a hospital that offers pediatric, gynecological, and orthopedic outpatient services may find it advantageous and more efficient to have each of these outpatient departments managed by a professional with a background and expertise in the relevant specialty and who is also responsible for these hospital departments in the inpatient setting. Rather than have just one individual, who may only have qualifications and experience in one of these areas, as the person responsible for only the outpatient services of all three specialties, hospitals would be able to make more efficient use of department directors who would oversee both inpatient and outpatient services for a particular specialty. In fact, the current regulations at § 482.54(a) require outpatient services to be, “integrated with inpatient services.”
Under the current requirement at § 482.54(b)(1), hospitals that are using multiple leaders must hire another director to oversee these highly qualified and expert directors who are already exercising responsibility for their respective areas, often for both inpatient and outpatient services. We have reason to believe, and feedback from stakeholders has confirmed that this situation may be causing unnecessary staff costs, increased administrative burden, and confused chains of command within a hospital regarding its management of patient services.
Therefore, in this proposed rule, we are proposing revisions to this CoP that would allow hospitals greater flexibility in determining the management structure of outpatient services that would be tailored to the scope and complexity of the services offered by an individual hospital. We propose to change the existing provision at § 482.54(b) by revising the provision at § 482.54(b)(1) to allow hospitals to assign one or more individuals to be responsible for outpatient services. We also propose to revise the current provision at § 482.54(b)(2), which currently requires a hospital to have appropriate professional and nonprofessional personnel available at each location where outpatient services are offered, by proposing to add a measure of flexibility such that hospitals would make their personnel decisions based on the scope and complexity of outpatient services offered.
On March 30, 2007, CMS published a final rule entitled “Medicare Program: Hospital Conditions of Participation: Requirements for Approval and Re-Approval of Transplant Centers To Perform Organ Transplants” (72 FR 15198). This final rule set forth hospital CoPs for the approval and re-approval of transplant centers at 42 CFR part 482, subpart E, including § 482.92, the section involving blood type and other vital data verification. Likewise, CMS addressed the regulatory requirements for organ procurement organizations in the 2006 final rule entitled “Medicare and Medicaid Programs; Conditions for Coverage for Organ Procurement Organizations (OPOs),” which published in the May 31, 2006 Federal Register (71 FR 30982). This rule set forth the Conditions for Coverage (CfCs) for OPOs, and it, too, included requirements for blood type verification. The transplant center and OPO rules were designed to work in tandem to achieve CMS' goals of safe, effective, and efficient care for all patients. However, since the time of publication, CMS has become aware of the potential for duplicative, overlapping efforts related to blood type verification. This proposed rule would address this unnecessary duplication by removing certain blood type verification requirements for transplant centers set forth at § 482.92(a).Start Printed Page 65898
As further described below, the requirements set forth in the transplant center rule at § 482.92(a) and in the OPO rule at § 486.344(d)(2)(ii) and § 486.344(e) are redundant and burdensome for providers as presently structured. Each blood type and other data verification requires documentation which must be physically signed and retained. For cases where the recovery is conducted by a surgeon on call for the OPO recovering for his/her own program, both the OPO and transplant center rules apply. As a practical matter, this has meant one set of paperwork for each entity, and, in some cases, a third set of paperwork maintained with the surgeon's records. The transplant hospital must maintain a copy of its signed verification and make it available for the onsite surveyors of its organ transplant program. OPOs maintain blood matching documentation for their onsite surveyors as well. In practice, for such cases, this means organ recovery teams must produce and protect two sets of paperwork alongside the recovered organs.
In order to reduce the amount of verification paperwork, CMS proposes to amend the existing regulations governing transplant centers by removing the provision at § 482.92(a) which requires the transplant team to verify blood type before organ recovery. We would redesignate current paragraph (b) and (c) as (a) and (b), respectively.
The current CoP at § 485.602 and § 485.635(b) require CAHs to furnish certain types of services directly rather than through contracts or under arrangements. Specifically, the CoP at § 485.635(b) requires CAH staff to provide, as direct services, (1) diagnostic and therapeutic services that are commonly furnished in a physician's office or at another entry point into the health care system; (2) laboratory services; (3) radiology services; and (4) emergency procedures.
We believe that what is most important in terms of quality and safety of care is that these required services are made available by the CAH, not that the qualified professionals providing those services be employees of the CAH. The proposed revisions to § 485.635(b) would eliminate the requirement that CAH staff must provide certain services directly and changes the heading of the standard, “Direct services,” to “Patient services.” We also propose to revise the language in paragraphs § 485.635(b)(1) through (b)(4), “that the CAH staff furnishes as direct services.” We believe the proposed revisions will provide CAHs with additional flexibility, increase the ability of CAHs to provide services that are required to ensure access to care, decrease burden on CAHs, and positively impact the costs of health care delivery. We also propose to eliminate the definition of “Direct Services” at § 485.602 since it will no longer be applicable.
The governing body, or the person principally responsible for the operation of the CAH under § 485.627(b)(2), would continue to be responsible for all services furnished by the CAH whether or not they are furnished directly, under arrangements, or under agreements. The governing body or responsible person must ensure that all furnished services enable the CAH to comply with all applicable conditions of participation and standards for the contracted services.
We propose to make a minor technical change to the requirement at § 482.25(b)(6). The current requirement states that drug administration errors, adverse drug reactions, and incompatibilities must be reported to the hospital's quality assurance program, if appropriate. Additionally, we propose to make a minor technical change to the requirement at § 482.42(b)(1). The current requirement states that the chief executive officer, the medical staff, and the director of nursing services must ensure that the hospital-wide quality assurance program and training programs address problems identified by the infection control officer or officers. Therefore, in both § 482.25(b)(6) and § 482.42(b)(1) we propose to replace the term “quality assurance program” with the more current term “quality assessment and performance improvement program.” This change would clarify that we expect drug errors, adverse reactions, and incompatibilities to be addressed in a hospital's QAPI program, as required at § 482.21.
Many of the former EACH/RPCH CoPs were adopted for the new CAH program (see 62 FR 46008, August 29, 1997), including the definition for clinical Start Printed Page 65899nurse specialist. In this NPRM we are proposing to revise the definition of a clinical nurse specialist at § 485.604(a) to reflect the definition in the statute at § 1861(aa)(5)(B). Specifically, we propose to change the definition at § 485.604(a) to state that a clinical nurse specialist is a registered nurse licensed to practice nursing in the State in which the clinical nurse specialist services are performed, that holds an advanced degree in a defined clinical area of nursing from an accredited educational institution.
Similar to the changes proposed in this rule that would allow a multi-hospital system the option of having a single governing body legally responsible for the conduct of the hospital (§ 482.12), we considered changes to the Medical staff CoP at § 482.22 that would allow a multi-hospital system the option of having a single organized medical staff responsible for the quality of medical care provided to patients by all of the hospitals in the system. Stakeholders have reported that multi-hospital systems have both integrated their governing body functions and their medical staff functions to oversee patient care in a more efficient manner.
The current language of § 482.22 states that the hospital “must have an organized medical staff that operates under bylaws approved by the governing body and is responsible for the quality of medical care provided to patients by the hospital.” We do not believe that the current Medical staff CoP language implies that we require a single and separate medical staff for each hospital within a multi-hospital system. Therefore, we have retained the current requirement without revision. However, based on the anecdotal evidence and input provided by stakeholders on this issue, we request comment on whether we need to propose any clarifying language.
We considered modifying the regulatory requirement at current § 482.24(c)(2) to clarify the intent of the rule in situations where a patient has received a medical history and physical examination (H&P) by either a non-hospital practitioner or a practitioner with hospital privileges prior to the patient's hospital visit. When an H&P has been completed for a patient within the most recent 30-day period prior to the patient's admission or registration, the current regulation requires a hospital to ensure documentation of, “[a]n updated examination of the patient, including any changes in the patient's condition. * * *”
We believe that some stakeholders may be interpreting our current requirements in a way that would require a hospital to conduct a full update to an H&P that was conducted within 30 days prior to the patient's admission or registration. As put forth in our November 27, 2006 final rule related to this issue (“Medicare and Medicaid Programs; Hospital Conditions of Participation: Requirements for History and Physical Examinations; Authentication of Verbal Orders; Securing Medications; and Postanesthesia Evaluations,” 71 FR 68673, 68675) and as stated in our current Interpretive Guidelines (CMS. “State Operations Manual.” Pub 100-07, Appendix A, http://cms.gov/​manuals/​Downloads/​som107ap_​a_​hospitals.pdf), a hospital may adopt a policy allowing submission of an H&P prior to the patient's hospital admission or registration by a practitioner who may not be a member of the hospital's medical staff or who does not have admitting privileges by that hospital, or by a qualified licensed individual who does not practice at that hospital but is acting within his/her scope of practice under State law or regulation. When an H&P is completed within the 30 days before admission or registration, the hospital must ensure that an updated medical record entry documenting an examination for any changes in the patient's condition is placed in the patient's medical record. This examination must be conducted by a practitioner who is credentialed and privileged by the hospital's medical staff to perform an H&P.
Currently, hospitals are required to meet the standards of the 2000 edition of the Life Safety Code (LSC), which is not the most recent edition. Many accrediting bodies, as well as state and local jurisdictions, require hospitals to comply with more recent versions, such as the 2003, 2006, or 2009 edition of the LSC. Complying with both the 2000 edition of the LSC, for Federal purposes, and a more recent edition, for accreditation or other purposes, can be challenging for hospitals when there are Start Printed Page 65900inconsistencies between the two versions.
According to CMS, there are about 4,900 hospitals (not including CAHs) that are certified by Medicare and/or Medicaid. We will use those figures to determine the burden for this rule. In addition, throughout this section, we estimate costs based on average hourly wages for different healthcare providers and attorneys. Unless indicated otherwise, we obtained these average hourly wages from the United States Bureau of Labor Statistics' “May 2010 National Occupational Employment and Wage Estimates United States” (http://www.bls.gov/​oes/​current/​oes_​nat.htm accessed on September 28, 2011). We also added 30 percent to the indicated average hourly wage to allow for overhead and fringe benefits.
Proposed § 482.13(g) would remove the current requirement for hospitals to notify CMS by telephone no later than the close of business the next business day following knowledge of a patient's death for patients who die when no seclusion has been used and the only restraints used on the patient were soft, non-rigid, cloth-like materials, which were applied exclusively to the patient's wrist(s). This requirement would include patients who died within 24 hours of having been removed from these types of restraints. In those cases, the hospital must report to CMS by recording in a log or other system the information required at proposed § 482.13(g)(2)(i) and (ii). We are proposing this change only for deaths where the patient died while either in soft two-point wrist(s) restraints or within 24 hours of having been removed from soft two-point wrist(s) restraints provided that: (a) There is no reason to believe the death was caused by those restraints, (b) that those were the only restraints used, and (c) that no seclusion was used.
In the currently approved OMB control number 0938-0328, we indicated that most of the patient-related activities, such as authentication of verbal orders and using standing orders, constituted a usual and customary business practice and did not assign a burden for this requirement in accordance with 5 CFR 1320.3(b)(2). However, we have reconsidered our analysis. We believe that the authentication of verbal orders should be governed by state law and not mandated by the Federal government. In addition, while writing orders is generally a usual and customary business practice in hospitals, hospitals can also choose how those orders will be conveyed. We believe that some hospitals are not currently using Start Printed Page 65901standing orders as often as they would choose to due to our CoPs. Therefore, by allowing authentication of verbal orders to be governed by state law and expanding the use of standing orders, we believe that these provisions would result in a burden reduction.
CMS had not reviewed the entire set of Conditions of Participation for Hospitals in many years. These requirements had grown over time and, while often revised, had not been subject to a complete review. CMS staff as well as CMS stakeholders, including TJC, the American Medical Association, the AHA, and many others, had identified problematic requirements over the years. Accordingly, we decided to conduct a retrospective review of the conditions of participation imposed on hospitals and to remove or revise obsolete, unnecessary, or burdensome provisions, and to increase regulatory flexibility while identifying and adding opportunities to improve patient care and outcomes. We analyzed all potential reforms and revisions of the CoPs for both the costs and the benefits that they would bring to hospitals and CAHs, Start Printed Page 65902Based on our analysis, we decided to pursue those regulatory revisions that would reflect the substantial advances that have been made in healthcare delivery and that would benefit hospitals and CAHs through cost savings.
Patient's Rights—Death Notice Soft Restraints 482.13 9,900
Medical Staff 482.22 330,000
Nursing Services—Care Plan 482.23 110,000
Medical Record Services—Authentication 482.24 80,000
Medical Record Services—Standing Orders 482.24 90,000
Infection Control—Eliminate Log 482.42 6,600
Outpatient Services 482.54 300,000
Transplant Organ recovery 482.92 200
CAH Direct Services 485.635 15,800
Total 942,500
There are about 4,900 hospitals and 1,200 CAHs that are certified by Medicare and/or Medicaid. We use these figures to estimate the potential impacts of this proposed rule. According to CMS' Center for Medicaid, Children's Health Insurance Program (CHIP), and Survey and Certification (CMCS), for fiscal year (FY) 2010, TJC accredited 3,839 hospitals and 365 CAHs. For TJC-accredited hospitals and CAHs we will use the figures of 3,800 and 400, respectively. For non TJC-accredited hospitals and CAHs, we will use the figures of 1,100 and 800, respectively. In addition, we use the following average hourly wages for nurses and physicians respectively: $45 and $124 (BLS Wage Data by Area and Occupation, including both hourly wages and fringe benefits, at http://www.bls.gov/​bls/​blswage.htm and http://www.bls.gov/​ncs/​ect/​). The analysis below overlaps with the Collection of Information Requirements section for many individual items. That section contains more technical and legal detail as appropriate under the Paperwork Reduction Act, but that is not necessary or appropriate in a Regulatory Impact Analysis. Readers may wish to consult both sections on some topics.
We estimate that full reporting of all such instances would result in 882,000 occurrences. This is much greater than the assumption that originally established this reporting requirement in the final rule (71 FR 71425). However, since the requirements have come into effect, we believe our initial estimate was low. Also, the assumption in the 2006 final rule was that these functions would be carried out by a clerical person. Based on our experience with hospitals, this assumption is incorrect. A registered nurse would be the more appropriate staff member to make the call and to enter the information into a patient's medical record. The difference between the average hourly wage for a clerical person and a registered nurse ($18.88 per hour versus $45 per hour) would account for a significant discrepancy in estimated burden between the 2006 final rule and this proposed rule. Similar to the 2006 rule, we still estimate that it would take about fifteen minutes (or .25 hours) to comply with this requirement for each occurrence. The estimate of the time is also based on our experiences with hospitals as well as feedback from stakeholders that indicates that this estimate is reasonable. Therefore, we estimate that this reduction in burden would reduce Start Printed Page 65903a hospital's burden hours by 45 hours each year valued at $45 per hour for an annual savings of $2,025. Thus, we estimate that for all 4,900 hospitals this would result in a savings of about $9,922,500.
The use of standing orders, order sets, and protocols reduces a hospital's burden in several ways. Initially, it saves the physician or other practitioner the time it takes to write out the orders. It also saves the physician the time it would take to go back to the chart or call a nurse with a verbal order if the physician forgets a particular order. The nurses also save time when standing orders are used. The orders are more legible so there is less time interpreting and calling physicians for verification. Nurses also need to call physicians less frequently when there is a change in the patient's condition or they feel there needs to be a change in the care the patient is receiving. Patients also benefit from standing orders because there would be less delay in the delivery of needed care to a patient. Thus, we believe that expanding the use of Start Printed Page 65904standing orders would significantly reduce the hospital's burden.
Based on these assumptions, this reform would produce $305 million annually in staff savings (3,267 hospitals × 2,000 hours × 2/3 × $70 per hour). A similar result would be obtained if four-fifths of hospitals redirected these functions, but the net hours saved were only a little more than half of the current hours.
Between July 1, 2009 and June 30, 2010, the United States saw 2,293 heart and 1,699 lung transplants. During the same time frame, there were also 16,679 transplants for kidneys, 6,301 for livers, and 371 for pancreases. (Scientific Registry of Transplant Recipients (SRTR) http://srtr.org/​csr/​current/​nats.aspx, date last accessed 6/9/10). Most organ recoveries for heart and lung transplants are conducted by surgeons working for their own transplant centers. By contrast, in the case of kidneys, livers, and pancreases, these organs are typically recovered by surgeons who are on-call for an OPO and who are not also working for, or privileged at, the same transplant center where the organ is delivered. For purposes of this analysis, we assume that 25 percent of kidney, liver and pancreas organ recoveries are conducted by surgeons who are working for the transplant centers. It is in this small percentage of transplant cases, roughly 5,800, together with the total number of heart and lung transplants, where the requirement for an additional verification has resulted in overlapping and burdensome requirements. For the purpose of analysis, we have assumed that conducting the verification and filing the corresponding paperwork would take 8 minutes and that there are 9,972 transplant cases. We therefore conclude that removing the duplicative verification requirement will result in an annual savings of 1,305 burden hours valued at $124 per hour for a monetary savings of $161,820.
A second set of alternatives arises because there are obviously various ways to draft each requirement. For each requirement that we have proposed for deletion or modification there are a number of possible options, including making no change, making the change Start Printed Page 65905we propose, and in some but not all cases making some in-between change. Most standards have an “either-or” nature, but we welcome comments on possible variations. There is a final set of alternatives revolving around entirely different methods of achieving potential benefits, such as incentive payments through Medicare or other health plans to high-performing institutions, or publishing quality scores to make hospital strengths and weaknesses transparent to both the public at large and to practitioners. A number of such reforms are underway. Likewise, there are alternatives such as technical assistance through Quality Improvement Organizations (QIOs) funded by CMS, also underway under the latest QIO contracts. We welcome comments on such alternatives.
As required by OMB Circular A-4 (available at http://www.whitehouse.gov/​omb/​circulars/​a004/​a-4.pdf), we have prepared an accounting statement. As previously explained, achieving the full scope of potential savings will depend on future decisions by hospitals, by State regulators, and others. Many other factors will influence long-term results. We believe, however, that likely savings and benefits will reach many billions of dollars. Our primary estimate of the net savings to hospitals from reductions in regulatory requirements that we can quantify at this time, offset by increases in other regulatory costs, are approximately $940 million a year. We welcome comments on both the overall estimate and its components.
−$940 2012 7% 2012-16
Annualized Monetized reductions in Costs $940 2012 3% 2012-16
In addition, section 1102(b) of the Social Security Act requires us to prepare a regulatory impact analysis if a rule may have a significant impact on the operations of a substantial number of small rural hospitals. This analysis must conform to the provisions of 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. We do not believe a regulatory impact analysis is required here for the same reasons previously Start Printed Page 65906described and because, in addition, our proposals are particularly cost-reducing for the smallest hospitals, including especially CAHs (which in most cases have no more than 25 beds).
§ 482.13
(5) The medical staff must examine the credentials of candidates applying for practice privileges and medical staff membership within the hospital, as well as the credentials of practitioners applying only for hospital practice privileges, and make recommendations to the governing body for the Start Printed Page 65907appointment of these candidates and the approval of these privileges in accordance with State law and hospital policies and procedures. A physician or nonphysician practitioner who has been granted practice privileges by the governing body for practice activities authorized within his or her State scope of practice is subject to all medical staff requirements contained in this section.
§ 482.23
(c) Standard: Preparation and administration of drugs. (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 as specified under § 482.12(c), and accepted standards of practice.
(i) Drugs and biologicals may be prepared and administered on the orders of other practitioners not specified under § 482.12(c) only if such practitioners are acting in accordance with State law, including scope of practice laws, and only if the hospital has granted them privileges to do so.
(ii) Drugs and biologicals may be prepared and administered on the orders contained within pre-printed and electronic standing orders, order sets, and protocols for patient orders only if such orders meet the requirements of § 482.24(c)(3).
(3) With the exception of influenza and pneumococcal polysaccharide 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 as specified under § 482.12(c).
(iii) Orders for drugs and biologicals may be documented and signed by other practitioners not specified under § 482.12(c) only if such practitioners are acting in accordance with State law and scope of practice and only if the hospital has granted them privileges to do so.
§ 482.24
(2) All orders, including verbal orders, must be dated, timed, and authenticated promptly by the ordering practitioner or another practitioner who is responsible for the care of the patient as specified under § 482.12(c) and authorized to write orders by hospital policy in accordance with State law.
(iii) Ensures that the periodic and regular review of such orders and protocols is conducted by the medical staff, in consultation with the hospital's Start Printed Page 65908nursing and pharmacy leadership, to determine the continuing usefulness and safety of the orders and protocols; and
(iv) Ensures that such orders and protocols are dated, timed, and authenticated promptly in the patient's medical record by the ordering practitioner or another practitioner responsible for the care of the patient as specified under § 482.12(c) and authorized to write orders by hospital policy in accordance with State law.
7. In § 482.25 paragraph (b)(6) is revised to read as follows:
§ 482.25
§ 482.42
§ 482.54
§ 482.92
§ 485.602
§ 485.604
(4) Emergency procedures. In accordance with requirements of § 485.618, the CAH provides medical services as a first response to common life-threatening injuries and acute illness.
§ 485.639