Wednesday, March 30, 2005

Medicare Proposes Updates to the Hospital Conditions of Participation

Below is a copy of the press release from The Centers for Medicare & Medicaid Services (CMS) regarding the proposed rule published in the Federal Register on March 25, 2005 modifying four of the current hospital conditions for participation (CoP).

The Federal Register version of the proposed rule can be found here. The final rule will be published after comments are received and reviewed by CMS. Comments on the proposed rule can be made either electronically or mail and must be submitted by May 24, 2005.

The proposed rule codifies earlier guidance issued by CMS's Survey & Certification Group on January 28, 2002, "Clarification of Hospital Admission and Presurgical History and Physical Examination (H&P) Requirements". The proposed rule states "[t]his proposed rule would codify the guidance provided in the January 28, 2002 memorandum . . . ."

One issue that I have already seen discussed among some of my health care lawyer colleagues is whether the proposed rule conflicts with JCAHO's H&P Update Requirements (see below) announced on December 3, 2004. I have yet to fully review this issue but it may be one worth looking at if you consider submitting comments on the proposed rule.


For Immediate release
CMS Office of Media Affairs
March 24, 2005


The Centers for Medicare & Medicaid Services (CMS) today announced a proposed rule to alleviate hospitals of overly burdensome regulations and allow doctors and nurses to focus more time and energy on patient care.

The proposed rule would revise requirements in the hospital conditions of participation (CoPs) for completion of history and physical (H&P) examinations, authentication of verbal orders, securing medications, and completion of post anesthesia evaluations.

"Based on extensive input from health professionals and the health care community, we are proposing to revise some specific aspects of our regulations to provide better support of the delivery of high-quality, up-to-date care at a lower cost," said CMS Administrator Mark B. McClellan, M.D., Ph.D.

These revisions were contained in the notice of proposed rule making (NPRM) published December 19, 1997, entitled "Medicare and Medicaid Programs; Hospital Conditions of Participation; Provider Agreements and Supplier Approval," which contained extensive revisions to the entire set of hospital CoPs. Other changes in the hospital CoPs are coming, building on these steps to avoid unnecessary burdens while promoting high-quality care.

"To keep up with changes in effective medical practice, we believe it is in the interest of the health care community as a whole for us to move forward with these changes," McClellan said.

The revised requirements include:
* H&P examination. The proposed requirement would expand the number of permissible practitioners who may perform the H&P and the time frame for its completion.

* Authentication of verbal orders. This regulation would require that all orders, including verbal orders, must be dated, timed, and authenticated by a practitioner responsible for the care of the patient. During a five year transition period from publication of the final rule, it would allow all orders, including verbal orders, to be dated, timed and authenticated by the prescribing practitioner or another practitioner responsible for the care of the patient. This would respond to public comments, reduce burden, and provide flexibility for hospitals in meeting the requirements for authentication of verbal orders. CMS expects that sunsetting this flexibility after a five year period is sufficient time for the adoption of changes in health care information technology to make it easy for prescribing practitioners to authenticate all of their own orders in a timely fashion. Additionally, the proposed rule states that in the absence of a State law specifying the timeframe for authentication of verbal orders, verbal orders would need to be authenticated within 48 hours. Finally, this requirement clarifies and reinforces current regulations regarding who may accept verbal orders, authentication of all orders for drugs and biologicals, and authentication of medical record entries.

* Security of Medications. This regulation requires that all drugs and biologicals be kept in secure areas, or locked when appropriate, to prevent unauthorized persons from obtaining access. This regulation addresses community concerns, provides flexibility for hospitals in determining control of nonscheduled drugs and biologicals, and is more patient-focused and outcome-oriented than the current requirement.

* Post anesthesia evaluation. This requirement permits the post anesthesia evaluation for inpatients to be completed and documented by any individual qualified to administer anesthesia. The current CoP requires that the individual who administers the anesthesia do this evaluation.

The intent of this proposed rule is to ensure that our requirements are consistent with current standards of practice, to provide hospitals and practitioners greater flexibility in meeting the needs of patients, and to reduce unnecessary regulatory burden for hospitals.

JCAHO's H&P Update Requirements December 3, 2004 (JCAHO's FAQ section for hospitals)

December 3, 2004H & P Update Requirements
Q: What are the requirements for histories and physical examinations and any updates?

A: The H & P must be performed within 24 hours of the inpatient admission (PC.2.120 EP 2) or you can utilize one that was performed up to 30 days prior to the inpatient admission or the outpatient services for which your medical staff per MS.2.10 EP 11 has determined require an H & P. It must be performed by a practitioner who has been granted privileges to do so (MS.2.10 EP 8). In 2004 at PC.2.120 EP 7 an update (by an LIP with privileges to perform H & Ps) is required at the time of admission when using an H & P that was performed before admission. This is different than in 2003 when the update was only needed when there were significant changes or the H & P was 8 - 30 days old as required by CMS. However, since the entire H & P must be performed and documented (in the format and location defined by the organization) and in the record within 24 hours, when using an H & P that was performed prior to admission or the outpatient procedure, the update can also be within 24 hours of the inpatient admission or at the time of the outpatient services for which your medical staff has determined require an H & P.
In addition the method (s) used to evaluate the patient to identify the need for any update to their condition and the detail and location of the update documentation would be defined by the organization. The admission H & P is good for the entire length of stay. There has never been a requirement for an update to the H & P within 24 hours prior to inpatient surgery. Any changes in the patient's condition prior to surgery would be documented in the progress notes.

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