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Medicare Proposes Revised Hospital Conditions
of Participation Relating to Certain Medical Records, Documentation,
and Medication Security Procedures
By Kathleen
H. Drummy and Susan
L. Fine
[April 2005]
On March 25, 2005 the Centers for Medicare and Medicaid Services
(CMS) proposed loosened requirements for “overly burdensome”
Conditions of Participation (CoPs) for:
These revisions will require hospitals to revise portions of
their medical staff bylaws and policies and procedures, and
communicate these changes to affected staff. In addition, with
loosened requirements, the role of policing will shift to hospital
governing bodies and administration. It would be wise for hospitals
to evaluate potential impacts of these revisions on their physicians,
staff, patients, systems of accountability, ability to minimize
errors, and potential for miscommunication. Any problems associated
with these changes will likely be handled through the hospital's
Quality Assessment and Performance Improvement Program and credentialing
process. Comments must be received no later than May 24, 2005.
Affecting the medical staff, medical records, nursing, pharmaceutical,
and anesthesia services CoPs, these proposed revisions are the
latest in CMS’s effort begun in 1997 to revise all the
regulatory hospital CoPs. These revisions conform certain Medicare
requirements to industry standards, and in some cases, codify
policies already implemented by survey agencies. All Medicare-
and Medicaid-participating hospitals are required to be in compliance
with the CoPs. Compliance is determined by state survey agencies
(SAs) or deemed status in accordance with accreditation organizations
like the Joint Commission on the Accreditation of Healthcare
Organizations (JCAHO), the American Osteopathic Association
(AOA), and other national accreditation programs approved by
CMS.
Completion of the Medical History and Physical
Examination
Current: Requires that a physical
examination and medical history (H&P) be done no more than
seven days before or 48 hours after an admission for each patient;
Proposed: Expands
the current requirement for completion of an H&P to within
30 days before admission as long as the hospital ensures documentation
of the patient’s current condition is in the medical record
within 24 hours after admission. (This conforms to JCAHO’s
revised standard that states an H&P performed within 30
days before admission may be used in the patient’s medical
record, provided any changes in the patient’s condition
are documented in the medical record at the time of admission.
It also codifies a Jan. 28, 2002 memo issued by Medicare’s
Survey and Certification Group (referenced as S&C-02-15)
and guidance published in the June 2003 issue of the Open Door
Forum Newsletter.)
Current: H&P must be performed by a doctor of medicine
or osteopathy. (For patients admitted only for oromaxillofacial
surgery, an oromaxillofacial surgeon who has been granted privileges
by the medical staff in accordance with state law may perform
the H&P.)
Proposed: A
physician (as defined in section 1861(r) of the Act), or other
qualified individual who has been granted these privileges by
the medical staff in accordance with state law, could complete
the H&P.
[Medical Staff (Sec. 482.22(c)(5)); Medical Record Services
(Sec. 482.24(c)(2)]
Authentication of Verbal Orders and
Documentation of Orders for Drugs and Biologicals
Current: All orders, including
verbal orders, must be dated, timed, and authenticated promptly
by the prescribing practitioner.
Proposed: For
five years from the effective date of the final rule, any practitioner
responsible for the care of the patient who is authorized by
hospital policy and permitted by State law to independently
write a specific order would be permitted to authenticate an
order, including a verbal order, even if the order did not originate
with him or her.
Proposed: Orders
for drugs and biologicals, including verbal orders, must be
documented and signed by a practitioner who is responsible for
the care of the patient as specified under Sec. 482.12(c) and
authorized to write orders by hospital policy in accordance
with state law. (Influenza and pneumococcal polysaccharide vaccines
are exceptions, which may be administered per physician-approved
hospital policy after an assessment of contraindications.) (This
intends to provide hospitals and medical staff the ability to
determine who may authenticate verbal orders and for whom.)
Current: Verbal orders must be dated, timed, and authenticated
“as soon as possible.” (CMS acknowledges that there
has been no consistency on this issue because some states have
laws requiring authentication of verbal orders within 24 to
48 hours. Other state laws, however, do not address timeframes
at all, and they defer to hospital policy.)
Proposed: All
verbal orders must be authenticated based upon federal and state
law. If there is no state law that designates a specific timeframe
for authentication of verbal orders, then verbal orders must
be authenticated within 48 hours.
[Nursing Services (Sec. 482.23); Medical Record Services (Sec.
482.24(c)(1))].
Securing Medications
Current: All drugs and biologicals
must be kept in a locked storage area.
Proposed: All
drugs and biologicals must be kept in a secure area, and locked
when appropriate. Drugs listed in Schedules II, III, IV, and
V of the Comprehensive Drug Abuse Prevention and Control Act
of 1970, however, must still be kept locked within a secure
area. Only authorized personnel may have access to locked areas.
Non-controlled drugs, however, do not necessarily need to be
locked. (A medication is considered secure if unauthorized persons
are prevented from obtaining access. Medications should not
be stored in areas that are readily accessible to unauthorized
persons. For example, medications left in an unlocked drawer
in a patient waiting area or patient examination room would
not be considered secure. However, if medications are kept in
a private office, or other area where patients and visitors
are not allowed without the supervision or presence of a health
care professional (for example, procedure room), they are considered
secure, even if not locked. Areas restricted to authorized personnel
only would generally be considered "secure'' areas.)
[Pharmaceutical Services (Sec. 482.25(b)(2))]
Completion of
the Postanesthesia Evaluation
Current: The individual who administers
the anesthesia must write the follow up report.
Proposed: Any
individual qualified to administer anesthesia may write the
follow up report.
[Anesthesia Services (Sec. 482.52(b)(3))]
For the text of the Proposed Rule, see CMS 3122-P, March 25,
2005.
Contact Information
The Payment and Accreditation Group at Davis Wright Tremaine
LLP assists community hospitals, physicians, nursing homes,
academic medical centers, critical access hospitals, DME suppliers,
pharmacies, ASCs, imaging centers, cancer hospitals, community
mental health clinics, and other specialized health care providers
in payment and accreditation matters, including obtaining coverage
for new services and products, obtaining the provider status
needed to obtain payment, resolving payment disputes, resolving
audits and investigations, and advising on compliance issues.
The group serves health care providers nationwide through five
of its offices in Washington, California, Oregon and Alaska.
For assistance with payment and accreditation matters or for
additional information, please contact:
M.
Steven Lipton, San Francisco, (415) 276-6550, SteveLipton@dwt.com
Edwin
D. Rauzi, Seattle, (206) 628-7761, EdRauzi@dwt.com
Kent
B. "Bernie" Thurber, Portland, (503) 778-5202,
BernieThurber@dwt.com
This Advisory is a publication
of the Health Law Department of Davis Wright Tremaine LLP. Our
purpose in publishing this Advisory is to inform our clients
and friends of recent developments in health law. It is not
intended, nor should it be used, as a substitute for specific
legal advice as legal counsel may only be given in response
to inquiries regarding particular situations.
Copyright © 2005, Davis Wright
Tremaine LLP.
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