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HEADLINES
Wednesday,
January 27, 2009
Click on a headline below for the
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On
The Front Lines
CCH®
Health Care Compliance Integrated
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Journal of Health Care Compliance January/February Volume 12, Number 1
In addition to regularly featured columns such as HIPAA, best practices, and compliance and quality, the January/February 2010 issue of the Journal of Health Care Compliance includes the following articles:
- FERA and the New World of False Claims Act Risks, written by Robert G. Homchick, Lisa R. Hayward, and David V. Marshall, provides examples of the implications of the new law expanding FCA use, and specifically, the revised scope of FCA liability.
- Thoughts on the Genetic Information Nondiscrimination Act of 2008 (GINA), written by Carmen McCormick and John E. Steiner, Jr., advises organizations on GINA compliance and provides a basic overview of the act.
- The 3 Cs of Research Billing Compliance: Collaboration, Challenges, and Compromise, written by Kelly Willenberg and Ryan Meade, focuses on the compliance issues faced by the management of clinical trials and stresses the need of effective communication and a strong infrastructure.
- Accountable Care Organizations and Evolving Integrated Delivery Systems—the New Frontier in Compliance Challenges, written by Paul R. DeMuro, explains that compliance officers must be aware of compliance issues in light of quality of care initiatives.
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The CCH HIPAA Security Guide January 2010 update
- The Office of the National Coordinator for Health Information Technology
plans to release white papers on various privacy and security issues to address how consumers will be able to grant permission if an exchange of health information is necessary, how to create a national network of health information exchanges, and whether or not individuals can opt-in or opt-out of having personal health records.
- Massachusetts has enacted a new privacy law, effective March 1, 2010, which requires all businesses that collect personal data on any individuals residing in the state to adopt a comprehensive written data security program, conduct internal and external security reviews, and complete employee training regarding their programs.
- Sample forms have been added to the Guide for use in the event of a security breach involving protected health information, including:
- 1) Protected Health Information Breach Notification Policy,
- 2) Breach Notification Letter,
- 3) Step 1. Management of Unauthorized Disclosure Information,
- 4) Step 2. Management of Investigation Process,
- 5) Step 3. Risk Assessment Questionnaire,
- 6) Step 4. Notification Process, and
- 7) Step 5. a Summary Report.
- Regulations from the Equal Employment Opportunity Commission, Internal Revenue Service, Labor Department, and Department of Health and Human Services that restrict the use of genetic information by health plans are discussed.
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Headlines
OIG: disclosure of adverse events limited
The Office of Inspector General (OIG) found
that public disclosure of information about adverse events was limited,
according to its review of 17 state adverse event report systems, eight
Patient Safety Organizations overseen by the Agency for Healthcare
Research and Quality (AHRQ), and the Centers for Medicare &
Medicaid Services (CMS).
Varying extent of disclosure among state systems. Among
the entities reviewed, seven state systems disclosed more extensive
information about the causes of adverse events and prevention strategies
than the other state systems. Three other state systems disclosed
less extensive information about the causes of the adverse events
and prevention strategies.
AHRQ. AHRQ anticipates
creating the Network of Patient Safety Databases (NPSD) to provide
an evidence-based management resource for providers, patient safety
organizations, and other entities. Patient Safety Organizations (PSOs)
will submit adverse event information received from hospitals to the
NPSD, which will allow AHRQ to receive and publicly disclose non-identifiable
adverse event information.
Once the NPSD is
operational, the Patient Safety Act requires that the data be used
to analyze national and regional statistics, including trends and
patterns of reported adverse events, and to generate two public reports
on: (1) effective strategies for reducing medical errors and increasing
patient safety, and (2) trend analysis results. The initial NPSD data
is estimated to be available for analysis and disclosure in early
2011.
CMS. CMS has selected ten categories
of conditions for the Medicare hospital-acquired condition policy,
and presently denies hospitals higher payment for Medicare admissions
complicated by the ten conditions. CMS is considering posting the
incidence of hospital-acquired conditions on its Hospital Compare
Website, which presently includes other quality measures about hospitals.
Medicare claims data, however, lack information about the causes of
hospital-acquired conditions or prevention strategies.
Patient privacy. Every entity reviewed by the OIG had patient privacy
protections in place that varied in scope.
OIG Report, No. OEI-06-09-00360, Jan. 5, 2010
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Immediate jeopardy finding fails due to lack of fact-finding specific analysis
A Department Appeals Board (DAB) order
upholding the finding of an immediate jeopardy level violation and
the imposition of $3,500 per day civil money penalty (CMP) against
a skilled nursing facility (SNF) was vacated by the Eighth Circuit
Court of Appeals because the DAB's finding was based on pure speculation
and not supported by substantial evidence contained in the administrative
record. The case focuses on the care provided to an 86-year-old female
resident in declining health who ultimately died.
The Eight Circuit found that the state agency and CMS based their immediate
jeopardy level charges on six interrelated deficiencies, not based
on the failure to investigate bruises observed during three-day period
prior to transfer to the hospital emergency room. According to the
court, the administrative law judge and the DAB, in effect, convicted
the SNF based on a violation not charged, yet the DAB made no fact-specific
analysis of the immediate jeopardy issue and cited no facts raising
an inference that the SNF's failure to investigate a doctor's statement
more promptly or thoroughly increased the risk of abuse. As a result,
the DAB's order of immediate jeopardy and imposition CMPs was vacated.
HHS was also directed to expunge all references to findings of immediate
jeopardy level noncompliance by the SNF in HHS and CMS records that
are accessible by any means to the public and ensure that the state
survey agency does the same.
Grace Healthcare of Benton v. CMS, 8th Cir., Dec. 21, 2009, Health Care Compliance
Reporter, ¶800,801
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Coding confusion creates jury question in qui tam action
The evidence in a qui tam action
against a medical supplier for submitting improperly coded bills to
Medicare and Medicaid showed confusion existed over the proper billing
codes and thereby created a jury question as to whether the supplier
acted "knowingly" or with "reckless disregard of
the truth or falsity" of the claims submitted. The government's
motion for summary judgment on their improper coding claims was denied.
A second allegation that the supplier altered prescriptions to call
for a more expensive back brace in order to receive higher reimbursement
was also a question for the jury to decide with regard to all of the
government claims except a single count to which the supplier previously
pled guilty to in a criminal proceeding. Summary judgment was granted
to the government on the civil count that corresponded to the criminal
count the supplier's president pled to. The remaining civil claims
must be considered by the jury at trial.
The court also
found that the corporate president's wife was not liable under the
guilty plea of the corporation because it was not certain whether
she was ever an officer of the corporation and all charges against
her had been dropped in the criminal action. Summary judgment against
the president's wife was denied.
U.S. ex. rel. Schaefer v. Conti Medical Concepts, Inc., et. al.,
W.D. Ky., Dec. 17, 2009, Health Care Compliance Reporter, ¶800,795
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Impact of the economy on compliance, HCCA/SCCE survey
The effect of the downturn in economy
on compliance budgets and staffing in 2009, and the compliance professional’s
expectations for 2010, are the subject of a joint survey of The Society
of Corporate Compliance and Ethics (SCCE) and the Health Care Compliance
Association (HCCA). The joint survey made the following findings:
2009 budgets and staffing. By the end of the 2009, 26 percent of
compliance professionals reported that their budget had increased
and 27 percent reported that their budgets had decreased.
2010 expectations. For 2010, approximately seven percent of survey
respondents anticipate their budgets will increase a great deal, and
26 percent expect a marginal increase.
Job security. When
respondents were asked if they feel that their job is more at risk
than others in their organization, 18 percent felt that their job
is somewhat more at risk and seven percent felt that their job was
much more at risk.
Management's perspective. Twenty-three
percent of the compliance professionals surveyed reported that management
sees compliance and ethics as a very positive asset in helping the
organization through the current economic conditions.
Perceived risk of failure. Fifty-four percent of respondents anticipated
that the current economy somewhat increases the risk of compliance
and ethics failures and 33 percent of respondents anticipated that
the economy greatly increased the risk of failures.
Warning. The
joint HCCA/SCCE report concludes that companies looking to cut budgets
may risk raising a red flag in the eyes of prosecutors and the courts;
and may find themselves having to explain why they are cutting compliance
spending while competitors are maintaining or increasing their budgets.
HCCA/SCCE Joint Survey; The Economy, Compliance, and Ethics; Dec. 2009
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Peer review privilege bars disclosure of physician data and documents
A doctor was not required to produce
a number of documents on the grounds that they were protected by the
state's peer review privilege. The peer review privilege precluded
discovery of documents or any other data generated by any peer review
committee engaging in peer review activities.
A peer review committee consists of one or more persons who act as
a committee of a specified entity, such as a group medical practice. Peer
review activities include activities that relate to matters affecting a
health professional's membership on the staff, matters affecting employment,
and evaluation of the qualifications, competency or performance of
any health professional.
The two individuals who had
brought suit against the doctor sought to compel a number of documents
from the group medical practice that employed the doctor, including:
minutes of the quality management committee (QMC) that discuss the
doctor's patients; documents reviewed by the QMC concerning the doctor;
documents relating to the board of director's meetings that discuss
the doctor's employment; and information provided to the state medical
association and state board of medical and osteopathic examiners.
The QMC, board of directors, state medical association and state
board of medical and osteopathic examiners fell under the definition of
"peer review committee" given that the matters at issue related to
the doctor's employment, competency, performance and qualification
as a health professional on the staff of the group medical practice.
Accordingly, they were barred by the state's peer review privilege.
The only documents that were not barred by the privilege were those
relating to the doctor's application for insurance because the insurer
did not engage in any peer review activity when reviewing the doctor's
application.
Uhing v. Callahan, D. N.D., Jan. 4, 2010, Health Care Compliance Reporter, ¶800,814
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On The Front Lines
Understanding HITECH- Regulations and Risks
Eric Nelson, CIPP
The Health Information Technology for Economic and Clinical
Health (HITECH) Act increases the challenges of protecting an individual's
personal health information, but also presents opportunities to increase
efficiencies, lower costs and ultimately raise the level of patient
care.
Although some questions remain, the HITECH requirements
have generally been defined and enforcement provisions are in place.
Most of the provisions of the Act take effect February 18, 2010; however,
the obligations to notify applies to all breaches discovered on or
after September 15, 2009, and increased penalties for HIPAA violations
were effective immediately.
Health care companies and their business associates need to
understand how these requirements apply to their organizations and
develop strategies to mitigate the risks and ensure compliance. Steps
to prepare for HITECH compliance include:
- Identify compliance requirements specific to your organization.
- Perform a risk assessment that includes an inventory of
protected health information (PHI) assets, including a thorough understanding
of how PHI is collected, managed and shared as well as how it is stored,
accessed and secured.
- Identify and prioritize high risk areas and revise existing
privacy and security policies and procedures to address these risks
and meet compliance requirements.
- Ensure employees and third parties receive privacy and
information security training and are constantly aware of their responsibility
to protect a patient’s personal health information.
- Review existing relationships between covered entities
and business associates and develop a contracting and compliance strategy.
- Develop an effective breach mitigation, detection and
response plan that includes internal staff as well as third parties
that collect, manage and share PHI.
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