Health Law Advisory Bulletin
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.
|
