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HEADLINES
Wednesday,
September 23, 2009
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Journal of Health Care Compliance September/October 2009 Volume 11, Number 5
In addition to regularly featured columns such as HIPAA, electronic resources, and compliance and quality, the September/October 2009 issue of the Journal of Health Care Compliance includes the following articles:
- Self-discovered Overpayments: Do I Have to Give the Money Back?, written by Donald H. Romano, discusses various civil and criminal statutes and an entity's obligation to self-report and refund overpayments.
- Inside Criminal Minds, written by Allan P. DeKaye, looks at those that have committed health care fraud and examines the traits that may lead to criminal behavior.
- Cultural Competency Compliance Issues in Health Care, written by Maria B.J. Chun, focuses on the federal and state requirements for health care entities related to cultural competency.
- Compliance with CMS "Never Event" Billing Requirements, written by Lisa M. Silveria, discusses the need to develop a multidisciplinary approach to remain compliant with "never event" billing requirements.
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The CCH HIPAA Privacy Guide Sept 2009 update
- Under the American Recovery and Reinvestment Act of 2009 (ARRA), doctors making meaningful use of health information technology (HIT) by 2012 and continuing to do so would receive the maximum $44,000 in incentives between 2011 and 2015. The new HIT Policy Committee, appointed by HHS under ARRA, introduced a proposal in July 2009 that would provide doctors and hospitals more time to meet basic meaningful use standards.
- A physician and two former employees of a Little Rock, Arkansas medical center pleaded guilty on July 20 to misdemeanor violations of the Privacy Rules, acknowledging they accessed patient records out of curiosity and without having any legitimate need to do so.
- A medical records administrator at a South Florida hospital and another defendant were charged with multiple criminal counts for allegedly stealing patient records and using the information in a credit card fraud scam.
- The Texas Supreme Court overturned a trial court’s protective order barring a defendant and his attorneys in a medical malpractice case from ex parte contacts with the plaintiff’s nonparty physicians. Finding that the plaintiff did not establish the providers in question ‘‘possessed irrelevant, privileged information’’ under state law, the court granted the defendant's request for mandamus.
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Headlines
Revised Common Formats for collecting safety data issued
The availability of an expanded and
enhanced Common Formats Version 1.0 and the process for its continued
development and refinement have been announced by the Agency for Healthcare
Research and Quality (AHRQ). As authorized by HHS, the AHRQ coordinates
the development of a set of common definitions and reporting formats
(Common Formats) that allow healthcare providers to voluntarily collect
and submit standardized information regarding patient safety events.
The initial release of the formats, Version 0.1 Beta, was announced
in the Federal Register on August 29, 2008 (73 FR
50974-50976). The Common Formats can be accessed electronically at
http://www.pso.ahrq.gov/index.html.
Reporting framework. The Patient Safety Act (42
U.S.C. §299b-21 to b-26) and Patient Safety Rule (42 C.F.R. Part
3) establish a framework by which doctors, hospitals, and other healthcare
providers may voluntarily report information regarding patient safety
events and quality of care. Information that is assembled and developed
by providers for reporting to patient safety organizations (PSOs)
and the information received and analyzed by PSOs—called “patient
safety work product”—is privileged and confidential. Patient
safety work product is used to identify events, patterns of care,
and unsafe conditions that increase risks and hazards to patients.
Common Formats. AHRQ's Common Formats include:
(1) descriptions of patient safety events and unsafe conditions to
be reported, (2) delineation of data elements to be collected for
specific types of events, (3) specifications for patient safety population
reports, (4) technical specifications for electronic data collection
and reporting, and (5) a user's guide.
Scope of Common Formats. The scope of Common Formats
applies to all patient safety concerns, including: (1) incidents—patient
safety events that reached the patient, whether or not there was harm,
(2) near misses or close calls—patient safety events that did
not reach the patient, and (3) unsafe conditions—circumstances
that increase the probability of a patient safety event.
The AHRQ welcomes industry feedback. Information on the feedback
process can be obtained at http://www.pso.ahrq.gov/index.html.
AHRQ Notice, 74 FR 45457, Sept. 2, 2009
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Hospice claims in nursing facilities found noncompliant, OIG
Eighty-two percent of hospice claims
for beneficiaries in nursing facilities in 2006 did not meet at least
one Medicare coverage requirement, according to the Office of Inspector
General (OIG). In 2006, Medicare paid approximately $1.8 billion for
these claims. Eighty-one percent of the claims did not meet at least
one Medicare coverage requirement relating to election statements,
plans of care, services or certifications of terminal illness, and
an additional one percent of the claims were undocumented (i.e., the
hospices did not submit any records to support the claims, as required).
Election statements. Thirty-three percent of hospice
claims did not meet election requirements. There were no election
statements for four percent of the hospice claims. For another 29
percent of the claims, the election statements did not comply with
one or more regulations. In most instances, the election statements
did not explain that hospice care was palliative, rather than curative,
or explain that the beneficiaries waived Medicare coverage of certain
services related to their terminal illnesses.
Plan of Care. Sixty-three percent of the claims
did not meet plan of care requirements. The hospices did not establish
plans of care for beneficiaries in one percent of the claims. For
another 62 percent of the claims, the plans did not meet at least
one federal requirement. These plans of care were not established
by interdisciplinary groups; did not include necessary components,
such as detailed descriptions of scope and frequency of services;
or did not specify intervals for review, as required.
Certification of terminal illness. In four percent
of hospice claims, the certifications were missing or did not meet
one or more federal requirements. Some deficiencies included: failure
to specify that the individual's prognosis was for a life expectancy
of six months or less if the terminal illness ran its normal course;
absence of supporting clinical information or other documentation
in the medical record; or absence of physician signatures.
The OIG recommended that CMS: (1) educate hospices about coverage
requirements and their importance in ensuring quality of care; (2)
provide tools and guidance to hospices to help them meet the coverage
requirements; and (3) strengthen its monitoring practices regarding
hospice claims. CMS concurred with all of the recommendations.
OIG Report, No. OEI-02-06-00221, Sept.
8, 2009
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EMTALA inapplicable to later-discovered emergency medical conditions
The U.S. District Court for the Eastern
District of Pennsylvania properly ruled in favor of several hospitals
and doctors who allegedly violated the Emergency Medical Treatment
and Active Labor Act (EMTALA), 42 U.S.C. § 1395dd, by failing
to stabilize and inappropriately transferring a patient, when the
patient in question did not present herself in an emergent state and
was not in an emergent state until she began to undergo monitoring
at the primary hospital.
Excluded patients. EMTALA's requirements are triggered
when an individual comes to the emergency department,
42 C.F.R. § 489.24(a)(1). Such an individual can only
come to the emergency department if that
person is not already a patient of the hospital. Under 42 C.F.R. §
489.24(b), a patient is defined as an individual who
has begun to receive outpatient services as part of an encounter . . . other
than an encounter that the hospital is obligated by this
section to provide. EMTALA does not apply to outpatients,
even if during an outpatient encounter, they are later found to have
an emergency medical condition and are transported to the hospital's
emergency department.
The Third Circuit Court of Appeals held that, contrary to the
parents' assertion, the mother did not come to the hospital with an
emergency medical condition. The mother was not in an emergent state
until after she began the monitoring at the primary hospital and her
condition quickly changed. Neither her previous complaints of discomfort
nor her high-risk pregnancy amounted to an emergency under EMTALA.
The circumstances failed to trigger EMTALA, and therefore precluded
the parents' EMTALA claim.
Actual knowledge requirement. The parents were
moreover required to prove that: (1) the mother had an emergency medical
condition, (2) the hospital actually knew of the condition, and (3)
the patient was not stabilized before being transferred. The parents'
EMTALA claim failed because they did not satisfy the requirement of
actual knowledge. For example, there was no evidence that any of the
hospital staff at the perinatal facility actually knew that the mother's
condition was an emergency before directing her to her primary hospital
for further monitoring. The Third Circuit accordingly held that the
parents' EMTALA claim was properly dismissed.
Torretti v. Main Line Hospitals, Inc., 3rd Cir., Sept. 2, 2009, Health Care Compliance Reporter, ¶800,724
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Patient stopped from bringing service animal into hospital
A patient was enjoined from bringing
any service animal into a hospital, and her Americans with Disabilities
Act (ADA) public accommodation claim was dismissed because of the
hospital's legitimate concerns regarding the animal.
The patient used a service animal to assist her, and kept the
dog in her room when admitted to the hospital, despite the nurses
being able to perform all assistance the dog provided. The dog suffered
from infections, caused allergy problems, and interfered with staff
duties. The hospital's requests that the patient's door be kept closed
and that a high efficiency particulate air (HEPA) filter be used were
refused by the patient and her husband.
While the patient and her dog were never denied admittance to
the hospital, the patient claimed that the treatment she received
from the hospital amounted to a violation of the public accommodation
requirement of the ADA. However, since no other service animal caused
these types of problems, and no other service animal owners claim
to be harassed for using a service animal, no violation of the public
accommodation requirement existed. Rather, the hospital, by requesting
the patient to address the hospital's legitimate concerns regarding
the animal, was attempting to accommodate patients, visitors and staff
by keeping them safe. The hospital moreover proved its affirmative
defense that the service dog posed a direct threat to the health and
safety of others.
An injunction enjoining the patient from bringing any service
animal into the hospital system's facilities was granted. Without
a service animal, the patient will create no further challenges for
the staff than those presented by other difficult patients.
Roe v. Providence Health System-Oregon, Aug. 31, 2009, Health Care Compliance Reporter, ¶800,722
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On The Front Lines
Stark Case on Exclusive Contract with Physicians in a Hospital Outpatient Department: Narrow Interpretation of Stark Exception
by Dennis M. Barry, J.D.
The Third Circuit Court of Appeals has sent shock waves
throughout the hospital community with a January 2009 decision in
the case of United States ex rel. Kosenske v. Carlisle HMA, Inc. The
court's opinion is not perfectly clear on the facts and, therefore,
it is not perfectly clear what the court's decision means.
The Third Circuit Court of Appeals reversed the district court
decision, and remanded to the district court for further proceedings.
There are five elements of the court's opinion that are noteworthy:
(1) the court held that exclusivity has value and, thus, an exclusive
contract creates a financial relationship that must fit within a Stark
exception; (2) the court also held that the office space furnished
to provider-based physicians had value and created a "financial relationship"
for which a Stark exception was required; (3) the fact, alone, that
a contract between a hospital and referring physicians is the product
of arms-length negotiations does not necessarily mean that the arrangement
is at "fair market value;" (4) the hospital in this instance erred
in not obtaining payment from physicians for the use of hospital space;
and (5) the court was stringent and unforgiving in determining whether
a Stark exception had been met.
Given the decision in this case, as well as other authorities,
providers should consider the following recommendations:
- Do not charge physicians for exclusive contracts; doing
so violates clear OIG guidance.
- Do have written contracts with hospital-based physicians.
To the extent that the hospital furnishes office space, clerical support,
or similar resources to the physicians, include that in the contract
as consideration (or additional consideration) for the physician's
agreement to furnish administrative services and to provide coverage
for the department for the agreed-upon hours.
- Be certain that all physician contracts are signed, have
not lapsed, cover all aspects of the arrangement, and are followed
by both parties
- If you are in a hospital under the jurisdiction of the
Third Circuit (New Jersey, Delaware, Maryland, and Pennsylvania),
consult with counsel on what additional steps, if any, are appropriate.
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