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HEADLINES
Wednesday,
October 7, 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 Security Guide October 2009 update
- Administration and enforcement of the Security Rules has been delegated to the HHS Office for Civil Rights (OCR), effective August 2009. Previously delegated to CMS, the move consolidates Privacy and Security Rules enforcement. OCR already enforces the Privacy
Rules, and the added responsibility is expected to increase efficiencies in the department’s efforts to ensure that health information privacy is protected, according to a press release from HHS.
- A consumer information organization called Consumers Checkbook was not entitled to HHS’ records for all Medicare claims submitted by physicians during 2004 because the records are
exempt from disclosure under the Freedom of Information Act (FOIA), according to the U.S. Court of Appeals for the D.C. Circuit.
- Effective September 23, 2009, HHS updated its guidance on security technology based on public comments. The update was part of the HHS interim final rule with request for comments on
breach notification issued on August 24, 2009.
- The FTC also published a final rule on August 25, 2009, effective September 24, 2009, regarding breach notification requirements for personal health records (PHR) vendors that are not
‘‘covered entities’’ or ‘‘business associates’’ under the Privacy Rules.
- To avoid overlap with the HHS regulations, HIPAA-covered entities and entities that engage in activities as business associates of HIPAA-covered entities will be subject only to HHS’ rule and not the
FTC’s rule.
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Headlines
Release of allegedly misleading health care reform information halted by CMS
All Medicare Advantage (MA) and Medicare
prescription drug plans have been ordered by CMS to immediately discontinue
any mailings regarding current health care reform legislation to Medicare
beneficiaries, as well as remove any related materials from their
website. The order followed CMS' discovery that an insurance company
was contacting enrollees, alleging that current health care reform
legislation could hurt seniors and disabled individuals causing them
to lose important benefits and services as a result of the legislation.
Potentially misleading information. “We are
concerned that the materials sent to our beneficiaries may violate
Medicare rules by appearing to contain Medicare Advantage and prescription
drug benefit information, which must be submitted to CMS for review,”
said Jonathan Blum, acting director of CMS’ Center for Drug
and Health Plan Choices. “We also are asking that no other plan
sponsors are mailing similar materials while we investigate whether
a potential violation has occurred.”
“We are concerned that, among other things, the information
in the letter is misleading and confusing to beneficiaries, who may
believe that it represents official communication about the Medicare
Advantage program,” said Blum. Specifically, CMS is investigating
whether the company inappropriately used the lists of Medicare enrollees
for unauthorized purposes.
GOP response. House Republican Leader John Boehner
(R-OH) responded to the memorandum by criticizing actions of the Obama
Administration to impose what he referred to as a gag order on critics
of the $500 billion in Medicare cuts proposed by the congressional
Democrats. He released a statement contending, It is outrageous
that the Obama Administration is trying to keep seniors in the dark
about the consequences of congressional Democrats’ costly government-run
health care bills.
CMS investigationCMS is currently investigating
the released information because the communications claim to convey
legitimate Medicare program information about an individual’s
specific benefits or other matters, but instead offer misleading
or confusing opinion and conjecture by the plan about the effect of
health care reform legislation on the Medicare Advantage program and
other information unrelated to a beneficiary’s specific benefits, according to CMS. The communications ultimately urge enrollees to
contact their congressional representatives to protest the proposals
referenced in the letter. These communications are potentially contrary
to federal regulations and guidance for the MA and prescription drug
programs and other federal law, including the Health Insurance Portability
and Accountability Act (HIPAA).
CMS Memorandum, Sept. 21, 2009, Health
Care Compliance Reporter, ¶350,121
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OIG: localities not fully prepared for pandemic influenza
An evaluation of ten selected localities
revealed that they were not fully prepared for the distribution and
dispensing of vaccine and antiviral drugs in response to an influenza
pandemic. The Office of Inspector General (OIG) has identified and
described eight broad components of vaccine and antiviral drug distribution
and dispensing planning:
- Receiving and staging involves identifying
locations where vaccines and antiviral drugs will be received and
staged, and developing procedures necessary to deliver them to dispensing
sites.
- Dispensing involves administering medications,
identifying facilities at which dispensing will occur, and developing
procedures to operate and staff these sites.
- Tracking involves managing vaccine and antiviral
drug inventories by implementing inventory management systems at state
or local stockpiles, receiving and staging locations, and dispensing
sites.
- Vulnerable populations refer to groups, such
as the homeless, prison inmates, and nursing home residents, which
may not have access to traditional dispensing sites.
- Priority groups are typically defined by
occupation or health status (e.g., health care personnel, pregnant
women). While HHS has developed preliminary guidance regarding priority
group definitions, states and localities are responsible for implementing
this guidance appropriately.
- Security for vaccines and antiviral drugs
involves protecting these medications at state or local stockpiles
and receiving and staging locations through the point of dispensing.
- Storage involves ensuring that the proper
environmental conditions are maintained at state or local stockpiles
and receiving and staging locations until the medications are dispensed.
- Transportation involves moving the medications
from state or local stockpiles and receiving and staging locations
to dispensing sites.
Recommendations. It was recommended that the Centers
for Disease Control (CDC) work with states to: improve local preparedness
by, for example, determining why localities appear to be in the early
stages of planning; ensure that localities consistently create both
After Action Reports and Improvement Plans; facilitate information
sharing and collaboration about existing pandemic influenza planning,
and encourage the use of existing resources.
The CDC agreed with the second and third recommendations, yet
did not indicate whether it agreed with the first recommendation,
although it stated it planned to use some of the suggested actions
to address this recommendation.
OIG Report, No. OEI-04-08-00260, Sept.,
2009
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Resolution reached regarding auxiliary aids for deaf patients
After the Office of Civil Rights (OCR)
found that a hospital violated the Rehabilitation Act of 1973 (Act)
by failing to provide an auxiliary aid or sign language interpreter
to a deaf patient that sought treatment in the emergency room, a resolution
agreement was reached between HHS and the hospital. During the deaf
patient's visit he was accompanied by his 11-year-old son; the patient
and his son requested a sign language interpreter and the patient's
wife called the hospital and asked that one be provided. Despite the
hospital's assurances that one would be provided, no interpreter ever
arrived. The patient's medical history, consent for treatment, diagnosis,
medication, and discharge instructions were all conveyed through the
patient's son. The hospital had a policy in place at the time of treatment
that stated that it will provide a qualified interpreter to a hearing
impaired person to facilitate the delivery of quality patient care.
In addition, the hospital had one portable telecommunication device
for the deaf (TDD) for use in the emergency room, which was not utilized.
The OCR found that the hospital failed to provide appropriate
auxiliary aids adequate to afford the patient effective communication.
Further, the hospital's failure to provide the patient with an interpreter
was inconsistent with the hospital's own policy regarding situations
which require a qualified interpreter, such as obtaining medical histories
and consent for treatment, making a diagnosis and giving medication
indications, and discharge instructions.
The hospital reached a resolution agreement with the OCR, in
which the hospital agreed to: (1) provide deaf or hard-of-hearing
patients and companions with full enjoyment of hospital services,
and not deny services, privileges, facilities, advantages, and accommodations;
(2) designate an individual to coordinate compliance with the Act;
(3) develop procedures to address complaints of discrimination; and
(4) develop a notice of nondiscrimination and inform patients, companions,
and personnel of the contents of the notice. The hospital also was
required to, among other things, revise its policies and procedures
to ensure that effective communication would be provided to hard-of-hearing
patients and companions, and maintain a log of requests for auxiliary
aids to submit to the OCR periodically along with compliance reports.
Office for Civil Rights Letter of Findings, Sept. 1, 2009, Health Care Compliance Reporter,
¶370,032
Resolution Agreement, Sept. 1, 2009,
Health Care Compliance Reporter, ¶370,033
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New PPS proposed for renal dialysis facilities
CMS has proposed a new prospective
payment system (PPS) for facilities that provide dialysis services
to Medicare beneficiaries who have end-stage renal disease (ESRD).
The proposed PPS would provide single bundled payments to dialysis
facilities and would improve care by establishing performance standards
for dialysis facilities and also contain the rapid growth in spending.
"Combining a fully bundled prospective payment system with required
performance standards would encourage facilities to operate more efficiently
and ensure that beneficiaries receive high quality care, while saving
dollars for both beneficiaries and the Medicare program," said Jonathan
Blum, director of the CMS Center for Medicare Management.
Pursuant to the Medicare Improvements for Patients and Providers
Act of 2008 (MIPPA) (PubLNo 110-275), the new PPS must trim 2.0 percent
of the estimated payments that would have been made in 2011 under
the previous payment scheme. The PPS will be effective January 1,
2011, and would provide for a four-year transition (phase-in) period
under which facilities would receive a blend of payments under the
prior case-mix adjusted composite payment system and the new ESRD
PPS.
Quality incentive program. The proposed PPS would
provide for a quality incentive program (QIP) that would apply to
renal dialysis services furnished on or after January 1, 2012, and
would help ensure that ESRD facilities furnished high quality care
to their patients by instituting financial incentives that would tie
a facility's Medicare payment rate to how well the facility performed
on quality of care measures. Facilities that do not meet or exceed
minimum performance standards in a period determined by HHS would
receive payment reductions of up to 2.0 percent of the payments otherwise
made. The payment reductions would apply with respect to the year
involved and would not be taken into account when computing future
payment rates.
The PPS would provide for measures and performance standards
for health care categories, such as measures on anemia management
and dialysis adequacy. The data needed to calculate these measures
would be collected from Medicare claims submitted by ESRD providers
and facilities on a patient-specific basis, which is the only complete
provider and facility level data set available to CMS at this time.
For this reason, CMS is proposing to adopt only two anemia management
measures and one dialysis adequacy measure.
Proposed Rule, 74 FR 49922, Sept. 29,
2009, Health Care Compliance Reporter, ¶730,074
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EMTALA duty to stabilize not triggered by transfer order
A claim of failure to stabilize a
patient under the Emergency Medical Treatment and Active Labor Act
(EMTALA) requires more than the mere order to transfer, but the actual
transfer of the patient. An end-stage renal disease dialysis patient
had arrived at the emergency room of the hospital, and complained
of chest pain and bleeding. The emergency room doctor ordered various
tests, and discussed the patient's condition with a nephrologist at
the hospital. The nephrologist subsequently ordered the patient's
admission to the medicine floor with further orders
for tests and a blood transfusion the next morning.
The next morning, a hospital surgeon evaluated the patient,
and recommended that the patient be transferred to another hospital
for surgery. Upon receipt of the recommendation, the nephrologist
ordered the transfer as soon as possible. Before the patient was transferred,
however, he died.
EMTALA stabilization provision. To establish a
violation of the stabilization provision in EMTALA, the family was
required to prove that: (1) the hospital was a participating hospital
covered by EMTALA that operated an emergency department, (2) the patient
arrived at the hospital seeking treatment, and (3) the hospital transferred
the patient without first stabilizing the emergency medical condition.
The family asserted, among other things, that EMTALA imposed an unqualified
duty to stabilize once it was determined that the patient had an emergency
medical condition; and, alternatively, even if the duty to stabilize
applied only when a patient was transferred, transfer
did not require a patient to physically leave the hospital, but
only for a physician to enter an order of transfer.
Contrary to the family's arguments, the duty to stabilize under
EMTALA does not impose a standard of care prescribing how the physicians
should treat the patient's condition. Rather, the law prescribes a
precondition the hospital must satisfy before it may transfer the
patient. Therefore, a hospital cannot violate the duty to stabilize
unless it transfers a patient. A transfer is defined
as the movement of an individual outside a hospital's facilities at
the direction of any person employed by the hospital.
While the nephrologist did order the transfer of the patient
to another hospital, the order did not effectuate a transfer
because the patient never left the hospital's facilities. Given
that no transfer occurred, the family failed to establish a stabilization
claim under EMTALA.
Alvarez-Torres v. Ryder Memorial Hospital, Inc.,
1st Cir., Sept. 4, 2009, Health Care Compliance Reporter, ¶800,727
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Ambulance service contracts not subject to OIG sanctions
In recent advisory opinions, the Office
of Inspector General (OIG) stated that it would not impose administrative
sanctions on two municipalities related to contracts with private
ambulance companies to provide exclusive primary response for emergency
ambulance calls. According to the OIG, even though the arrangements
could potentially implicate the anti-kickback statute, both of the
arrangements contained factors that mitigated the risk of federal
health care program fraud and abuse.
The arrangements called for the ambulance companies to annually
reimburse the municipalities for their costs incurred in operating
911 dispatch centers and, with one municipality, for it to monitor
the company's performance. These kinds of arrangements would be considered
prohibited remuneration under the Anti-Kickback Statute pursuant to
section 1128B(b) of the Social Security Act because the companies
were required to pay an annual remittance as part of their exclusive
contract when some of those costs would be reimbursable under federal
health care programs.
However, the risk of fraud or abuse is mitigated because the
arrangements: (1) are part of comprehensive regulatory schemes to
manage the delivery of emergency medical services; (2) provide compensation
for the approximate costs of dispatch services; (3) fees are not related
to volume or value of the referrals; (4) are limited to emergency
medical services; (5) would not adversely impact competition; (6)
inure to public rather than private benefits; and (7) do not represent
a fundamental change in the delivery of emergency response services.
Therefore, the proposed arrangements would not constitute grounds
for the imposition of sanctions under the exclusion authority of the
Act.
OIG Advisory Opinion, No. 09-14, Aug.
27, 2009, Health Care Compliance Reporter, ¶500,219
OIG Advisory Opinion, No. 09-15, Aug.
27, 2009, Health Care Compliance Reporter, ¶500,220
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On The Front Lines
The ADA Amendments Act: Expanded Disability Challenges for Health Care Employers
by William P. Schurgin, Esq. and Kristen McGurn, Esq.
This year, over sixteen years after the employment provisions
of the Americans with Disabilities Act (ADA) first went into effect,
the Americans with Disabilities Amendments Act of 2008 (PubLNo 110-325)
(ADAAA) has changed the landscape of disability discrimination in
the workplace. The ADAAA significantly broadens the definition of
disability under the ADA, states that employers should generally not
consider mitigating measures when assessing whether an employee is
entitled to the statute’s protection, and requires employers
to change the way they evaluate whether a worker has a disability
and how they handle medical impairments in the workplace.
The original ADA defined “disability” to include
an individual who:
- has a physical or mental impairment that substantially
limits one or more major life activities; or
- has a record of impairment; or
- is regarded as having an impairment; or
- has a relationship or association with someone who has
a known disability.
The ADAAA retains the same definitional language as the original
statute but explicitly states that “disability” must be
construed broadly so that the statute’s coverage applies “to
the maximum extent.” In this regard, the statute states that
the question of whether an individual’s impairment is a disability
under the ADAAA “should not demand extensive analysis.”
The ADAAA also flatly rejects several Supreme Court rulings
that Congress believed led lower courts to incorrectly exclude many
people with disabilities from the protections of the statute. Going
forward, this means that many of the court cases that had analyzed “disabilities”
under the ADA will be of little value under the ADAAA. As a practical
matter, until a new body of law develops under the ADAAA, health care
employers will need to consider almost any medical or mental condition
a potential disability under the ADAAA—other then truly transitory
illnesses and injuries.
The ADAAA has changed the playing field for evaluating and responding
to disability discrimination issues in the health care workplace.
As a result, health care employers need to carefully reevaluate their
existing procedures for addressing disability issues in the workplace.
In doing so, employers should place particular emphasis on the reasonable
accommodation process and delineating essential job functions and
legitimate job qualifications.
Reprinted with the permission of Seyfarth Shaw LLP.
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