Executive Summary.
On October 24, 2011, the Centers for Medicare and Medicaid Services (“CMS”) released a proposed rule (“Proposed Rule”) to revise a number of hospital and critical access hospital (“CAH”) conditions of participation (“CoPs”). The revisions would implement the President’s Executive Order 13563 calling for the removal or revision of obsolete, duplicative or unnecessary regulatory provisions in order to reduce burdens and costs for hospitals and CAHs. If finalized, hospitals and CAHs will benefit from the revisions, as CMS seems to have responded to some of the financial pressures, unnecessary regulatory burdens and personnel limitations faced by hospitals and CAHs. The Proposed Rule can be found at: http://www.gpo.gov/fdsys/pkg/FR-2011-10-24/pdf/2011-27175.pdf.
CMS invites comments on the Proposed Rule, which must be received by CMS no later than 5 p.m. on December 23, 2011. Commenters should refer to file code CMS-3244-P and should submit comments in accordance with instructions described in the Proposed Rule.
The Proposed Revisions – Hospitals. The following summarizes the proposed revisions to the hospital conditions of participation found in Part 482 of the Medicare regulations.
Governing Body Requirements (42 C.F.R. §482.12)
Current CoP. The Governing Body CoPs, as currently interpreted, require each hospital facility to have a separate governing body.
Proposed Revision. CMS is proposing to permit hospitals in a multi-hospital system (defined as those systems having more than one CMS certification number) to have a single governing body. This should allow systems, when appropriate and desired, to streamline administration and allow for consistency in practices.
Patient’s Rights Requirements (42 C.F.R. §482.13)
Current CoP. Under 42 C.F.R. §482.13(g) addressing certain reporting requirements related to restraint or seclusion-related deaths, hospitals must report no later than the close of business on the next business day following knowledge of the patient’s death: each death that occurs while the patient is in restraint or seclusion or within 24 hours after removal from restraint or seclusion; and each death known to the hospital that occurs within 1 week after restraint or seclusion where it is reasonable to assume that the restraint or seclusion contributed directly or indirectly to the patient’s death.
Proposed Revisions. Due to the absence of any research findings suggesting that the use of soft, two-point wrist restraints has resulted in any patient deaths, CMS proposes to loosen the reporting requirements. Under the Proposed Rule, if the circumstances of a patient’s death only involved the use of soft wrist restraints without seclusion, the hospital would be obligated to report the death within 7 days after the date of death via a log or other system and make the log or other system accessible to CMS upon request. The log should include, at a minimum, patient name, dates of birth and death, attending physician’s name, primary diagnosis and medical record number.
In addition to modifying the reporting requirements for no seclusion/soft wrist restraint-related deaths, CMS is also proposing to provide alternative means of notifying CMS with respect to seclusion and/or other restraint-related deaths to include, in addition to telephone notification, reports by fax or electronic reporting.
Medical Staff Requirements (42 C.F.R. §482.22)
Current CoP. 42 C.F.R. §482.22(a)(2) currently states the medical staff must examine credentials of candidates for medical staff membership and make recommendations to the governing body on appointment of such candidates. 42 C.F.R. §482.22(b)(3) currently states medical staff management positions may be assigned only to MDs, DOs or, if state law permits, DDSs or DMDs.
Proposed Revisions. CMS proposes to revise the language of this subsection to make it clear that a hospital may privilege physicians as well as non-physicians within their state-designated scope of practice even if the practitioners do not seek medical staff membership. In other words, practitioners may be granted practice privileges without formal appointment to the medical staff. All practitioners granted practice privileges, even in the absence of medical staff appointment, would be subject to generally the same medical staff requirements and approval process described in §482.22. In addition, the Proposed Rule would expand eligibility for medical staff management positions to doctors of podiatric medicine (“DPM”) as permitted by state law (e.g., a DPM could be elected president of the medical staff). CMS proposes these medical staff changes to give hospitals necessary flexibility to address health care workforce shortages and to meet the needs of their communities.
Nursing Services Requirements (42 C.F.R. §482.23)
Current CoP. Presently, the nursing CoPs require the nursing staff to maintain a current nursing care plan for each patient. Further, nursing staff may only prepare and administer drugs and biologicals on the order of MDs, DOs and other select practitioners authorized to care for hospital inpatients, and may only administer blood transfusions and intravenous medications (“IV Meds”) if they have special training. Patients generally are not permitted to self-administer medications while hospitalized, with few exceptions.
Proposed Revisions. CMS proposes to revise the regulations to permit the hospital to integrate the nursing care plan into the overall hospital interdisciplinary care plan. Thus, two care plans for nursing services no longer would be required. Further, under the revised CoPs, nursing staff would be permitted to prepare and administer drugs and biologicals ordered by midlevel practitioners such as APRNS, PAs and Doctors of Pharmacy subject to state scope of practice laws and appropriately granted hospital privileges, or pursuant to pre-printed and electronic standing orders, order sets and protocols. Additionally, nursing staff no longer would require special training for administration of blood transfusions and IV Meds, and patients or their caregivers would be permitted to self-administer certain home or hospital-issued drugs and biologicals, if the hospital develops policies and procedures covering this practice. Hospital policies would need to address such concerns as the necessity of an order permitting self-administration of medications and the assessment of patients and caregivers to ensure that they have the capacity to self-administer meds safely. Overall, the proposed revisions to the nursing services CoPs provide for more efficient delivery of care and for maximum utilization of hospital personnel, but appropriate policies and procedures will be important.
Medical Record Services Requirements (42 C.F.R. §482.24)
Current CoP. The medical record services CoPs require all orders, including verbal orders, to be dated, timed and authenticated promptly by the ordering practitioner, or by another practitioner responsible for the patient’s care and authorized by hospital policy to write orders (this provision is scheduled to sunset in January 2012). Verbal orders must be authenticated within the specific timeframe specified by state law or, if state law is silent, within 48 hours.
Proposed Revisions. CMS proposes to eliminate the sunset provision described above so that “another practitioner responsible for the patient’s care” may continue to date, time and authenticate orders written by such other practitioner. It also proposes to strike the 48-hour requirement for authentication of verbal orders, opting instead to defer to state law or hospital policy for the required timing on authentication of verbal orders.
CMS would allow hospitals to use standing orders and protocols if certain requirements are satisfied. For example, standing orders and protocols would need to be reviewed and approved by the medical staff in consultation with the hospital’s nursing and pharmacy leadership and periodically re-reviewed to determine continued usefulness and safety. Such orders and protocols would need to be consistent with nationally recognized evidence-based guidelines. Further, hospitals would need to ensure that such orders and protocols are dated, timed and authenticated promptly in the patient’s medical record. CMS commented that: (i) protocols and standing orders must be medically necessary for the patients to whom they are applied; (ii) staff initiating such orders must do so only within their scope of practice; and (iii) a hospital should set forth specific criteria (e.g., specific situations, patient conditions or diagnoses) for nurses and other personnel to follow when initiating orders and protocols. Standing orders could benefit patient care in several areas in a hospital, including the emergency room and post-operative recovery.
Infection Control Requirements (42 C.F.R. §482.42)
Current CoP. The current CoPs require the hospital infection control officer to maintain a log of incidents related to infections and communicable diseases.
Proposed Revision. CMS proposes to rescind the infection log requirement in favor of allowing hospitals flexibility in their infection tracking and surveillance activities.
Outpatient Services Requirements (42 C.F.R. §482.54)
Current CoP. Presently, hospitals providing optional outpatient services must assign one individual to be responsible for the outpatient services.
Proposed Revision. In view of the significant expansion and complexity of hospital outpatient services offered since the affected CoP was originally promulgated, CMS has proposed to permit hospitals to assign one or more individuals to be responsible for outpatient services. Accordingly, hospitals using multiple outpatient services directors to manage different clinical services need not hire another director merely to oversee these directors. This revision is a further effort at reducing staff costs, increasing overall health care delivery efficiencies and allowing for better integration with inpatient services.
Transplant Center Process Requirements – Organ Recovery and Receipt (42 C.F.R. §482.92)
Current CoP. Currently, the CoPs for transplant center organ recovery and receipt and the Conditions for Coverage for Organ Procurement Organizations are unnecessarily duplicative with respect to blood type verification requirements resulting in at least two sets of paperwork.
Proposed Revision. To reduce the amount of blood type verification paperwork and the associated costs, CMS proposes to amend the transplant center CoPs to eliminate the requirement that transplant teams verify blood type before organ recovery.
The Proposed Revisions – CAHs. The following summarizes the proposed revisions to the CAH conditions of participation found in Part 485 of the Medicare regulations.
Definitions (42 C.F.R. §485.602) and Provision of Services (45 C.F.R. §485.635)
Current CoP. The current CoP requires CAHs to provide as direct services (with their own employees): (i) diagnostic and therapeutic services commonly furnished in a physician’s office or at another entry point in the health care system; (ii) laboratory services (includes: urinalysis by stick or tablet method, hemoglobin/hematocrit, stool sample examination, pregnancy tests and primary cultures for transmittal to a certified lab); (iii) radiology services; and (iv) emergency procedures as a first response to common life-threatening injuries and acute illness. Specifically, CAHs cannot provide these services by using independent contractors, under arrangements with another provider or via contractual agreements.
Proposed Revisions. Recognizing that CAHs have special challenges, including workforce shortages, small size, limited resources and somewhat remote locations, CMS proposes to lessen the burden on CAHs and promote access to care by amending the CoPs to permit CAHs to provide services through contractual arrangements. In CMS’s words, “[w]e 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.” Thus, CMS proposes to change the heading of §485.635(b) from “Standard: Direct Services” to “Standard: Patient Services” and to eliminate all references to “direct services” in this context. CMS still expects the governing body or person responsible for the operation of the CAH to be responsible for all CAH services regardless of whether the services are provided directly, by contract or under arrangements. Related to this, the CAH must continue to be able to meet all applicable CoPs and standards for any contracted services. This change will allow some CAHs to more easily provide basic required services and to expand services otherwise unavailable due to the inability or expense associated with employing qualified personnel.
Personnel Qualifications (42 C.F.R. §485.604)
Current CoP. The current CoP defines “clinical nurse specialist” as “a person who performs the services of a clinical nurse specialist as authorized by the State, in accordance with State law or the State regulatory mechanism provided by State law.”
Proposed Revision. CMS proposes to update the definition of “clinical nurse specialist” as follows: “A clinical nurse specialist must be a person who is a registered nurse and is licensed to practice nursing in the State in which the clinical nurse specialist services are performed; and holds an advanced degree in a defined clinical area of nursing from an accredited educational institution.”
Surgical Services (42 C.F.R. §485.639)
Current CoP. The current CoP requires CAHs to provide surgical services in a safe manner by qualified practitioners.
Proposed Revision. The proposed revision, merely technical in nature, clarifies that CAHs are not obligated to provide surgical services.
Other Options Considered.
In addition to the proposed revisions summarized above, in this Proposed Rule, CMS considered, but did not actually propose, certain additional changes for which it now seeks stakeholder comments. The relevant areas are discussed briefly below:
Medical Staff Issues. 42 C.F.R. §482.22 currently states that a 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.” CMS does not interpret this provision to require that each hospital within a multi-hospital system have a single separate medical staff. Accordingly, at this time, CMS has not proposed any changes to this provision. CMS recognizes that there has been confusion related to this CoP and seeks comments as to whether it should propose any clarifying language.
Medical Record Services. 42 C.F.R. §482.24 states that when a history and physical (“H&P”) has been performed within the most recent 30-day period prior to the patient’s admission or registration, the hospital must ensure that an updated medical record entry documenting an examination for any changes in the patient’s condition, performed by a hospital privileged medical staff member, is placed in the medical record. CMS clarified that it does not specify the “extent of the [updating] examination that must be conducted” (i.e., it does not require a “full update” to the H&P), leaving this up to the judgment of the medical staff member performing the examination. While CMS does not believe §482.24 requires revision, it seeks comments in this regard.
Physical Environment. 42 C.F.R. §482.41 currently requires hospitals to meet the standards of the 2000 edition of the Life Safety Code (“LSC”) even though certain accrediting bodies and state and local jurisdictions require compliance with more recent versions of the LSC. CMS is considering whether to incorporate by reference the 2012 or another recent version of the LSC and seeks stakeholder comments.
Practical Considerations.
In anticipation of the finalization of the Proposed Rule, hospitals should begin to review applicable medical staff bylaws as well as hospital/CAH policies and procedures. Changes to either the bylaws or policies and procedures will be necessary to implement many of the proposed changes if finalized. For example, if a hospital wishes to implement the use of standing orders and order protocols, or patient self-administration of medications, new or revised policies will need to be developed, vetted and approved. Hospitals should educate staff (both physicians and non-physicians) to ensure they understand the new processes and to ensure patient safety and quality of care.
CAHs having trouble meeting their direct services requirements will have the option to provide the services, including lab and radiology services, under contract. During the comment and finalization period to follow this Proposed Rule, CAHs can begin exploring alternative service arrangements if this will help them continue to provide critical services and maintain access to care.
Finally, hospitals and CAHs should consider whether they would benefit from submission of comments on this Proposed Rule.
If you have any questions, would like additional information about this topic or need help preparing and submitting comments, please contact your regular Hall Render attorney or:
