Medicare Proposes Payment Rules to Protect Senior
Citizens from Three Never Events
CMS asks for comments on three National Coverage
Determinations about preventable surgical errors
Dec. 3, 2008 - The Centers for Medicare & Medicaid
Services (CMS) proposed yesterday three national coverage determinations
(NCDs) to establish uniform national policies that will prevent Medicare
from paying for certain serious, preventable errors in medical care. The
following errors, called “Never Events,” being focused on by Medicare
through the NCDs are identified in the National Quality Forum’s (NQF’s)
list of Serious Reportable Events:
● Wrong surgical or other invasive procedures
performed on a patient;
● Surgical or other invasive procedures
performed on the wrong body part; and
● Surgical or other invasive procedures
performed on the wrong patient.
“These types of surgical errors can cause serious
injury or death to beneficiaries and result in increased costs to
Medicare due to the need to treat the consequences of the errors,” said
CMS Acting Administrator Kerry Weems. “The proposed national coverage
policies for certain types of surgical errors are important steps for
Medicare in working to reduce or eliminate their occurrence and their
associated payments.”
In 2002, prompted in part by the release of the
1999 Institute of Medicine report titled, “To Err is Human: Building a
Safer Health System,” the NQF created a list of 27 Never Events, which
was expanded to 28 events in 2006.
The NQF defines Never Events as errors in medical
care that are clearly identifiable, preventable and serious in their
consequences for patients.
Decision Summary
Pertaining to Wrong Body Part
The Centers for
Medicare and Medicaid Services (CMS) proposes that when a Medicare
beneficiary requires a particular surgical or other invasive procedure
to treat a particular medical condition and the practitioner erroneously
performs that procedure on the wrong body part, Medicare will not cover
that procedure because it is not a reasonable and necessary treatment
for the Medicare beneficiary’s particular medical condition.
A surgical or other
invasive procedure is considered to have been performed on the wrong
body part if it is not consistent with the correctly documented informed
consent for that patient. It includes surgery on the right body part,
but on the wrong location on the body; for example, left versus right
(appendages and/or organs), level (spine). It excludes emergent
situations that occur in the course of surgery and/or whose exigency
precludes obtaining informed consent. The event is not intended to
capture changes in the plan upon surgical entry into the patient due to
the discovery of pathology in close proximity to the intended site when
the risk of a second surgery outweighs the benefit of patient
consultation; or the discovery of an unusual physical configuration
(e.g., adhesions, spine level/extra vertebrae).
Surgical and other
invasive procedures are defined as operative procedures in which skin or
mucous membranes and connective tissue are incised or an instrument is
introduced through a natural body orifice. Invasive procedures include a
range of procedures from minimally invasive dermatological procedures
(biopsy, excision, and deep cryotherapy for malignant lesions) to
extensive multi-organ transplantation. They include all procedures
described by the codes in the surgery section of the Current Procedural
Terminology (CPT) and other invasive procedures such as percutaneous
transluminal angioplasty and cardiac catheterization. They include
minimally invasive procedures involving biopsies or placement of probes
or catheters requiring the entry into a body cavity through a needle or
trocar. They do not include use of instruments such as otoscopes for
examinations or very minor procedures such as drawing blood.
We are requesting
public comments on this proposed determination pursuant to section
1862(1) of the Social Security Act. After considering the public
comments, we will make a final determination and issue a final decision
memorandum.
Included in the list of Never Events as a Surgical
Event, for example, is surgery performed on the wrong body part.
Medicare beneficiaries experience serious injury
and/or death due to surgeries performed on the wrong body part and
additional costs are incurred by Medicare in order to correct adverse
outcomes resulting from these errors.
In order to address and reduce the occurrence of
these surgeries CMS has decided to internally generate a national
coverage analysis (NCA) to develop a national coverage determination
(NCD) regarding coverage and payment for surgeries performed on the
wrong body part.
As part of the ongoing implementation of Section
5001(c) of the Deficit Reduction Act (DRA) of 2005, CMS has addressed
some of the NQF Never Events through the Hospital-Acquired Conditions
(HACs) provisions in the Inpatient Prospective Payment System (IPPS)
final rule for fiscal years (FY) 2008 and 2009.
For discharges occurring on or after October 1,
2008, Medicare will no longer pay a hospital at a higher rate for an
inpatient hospital stay if the sole reason for the enhanced payment is
one of the selected HACs, and the condition was acquired during the
hospital stay.
CMS is also exploring how to adapt this policy to
its other payment systems.
In the IPPS FY 2008 final rule, CMS selected eight
conditions for the HAC list, a number of which were among the 28 Never
Events listed by the NQF and include -
● retained foreign object after surgery,
● air embolism,
● blood incompatibility,
● stage III & IV pressure ulcers, and
● falls and traumas such as electric shock and burns.
In the IPPS FY 2009 final rule, CMS added
manifestations of poor glycemic control, including hypoglycemic coma, to
the list. Hypoglycemic coma is closely related to NQF’s listing of death
or serious disability associated with hypoglycemia.
CMS determined that not all conditions included on
the NQF list of Never Events can be adequately addressed by the HAC
payment provision and therefore determined that the NCD process was
appropriate to address coverage for the three types of surgical errors
cited above.
Unlike the HAC provisions, which affect only
payments to hospitals for inpatient stays, the final NCDs could affect
payment to hospitals, physicians, and any other health care providers
and suppliers involved in the erroneous surgeries.
CMS will accept comments from the public regarding
the proposed coverage policies until January 1, 2009. Comments should
be submitted separately for each of the NCDs. Following the close of
the 30-day public comment period, CMS will issue final NCDs within 60
days.
NOTE: For more information, including information
about how to submit comments on each of the proposed NCDs, please see:
Dec. 3, 2008 - The Centers for Medicare & Medicaid
Services (CMS) proposed yesterday three national coverage determinations
(NCDs) to establish uniform national policies that will prevent Medicare
from paying for certain serious, preventable errors in medical care. The
following errors, called “Never Events,” being focused on by Medicare
through the NCDs are identified in the National Quality Forum’s (NQF’s)
list of Serious Reportable Events:
Physicians in both the
e-prescribing and PQRI initiatives would receive a 5.1% bonus in
Medicare payments next year