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HEADLINES
Wednesday,
September 9, 2009
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On
The Front Lines
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Health Care Compliance Professional’s Manual Highlights
Endorsed by the Health Care Compliance Association and written by expert compliance practitioners, the Health Care Compliance Professional’s Manual provides the information and tools needed to plan and execute a customized program that meets federal and state standards. Report 21 includes the following new and revised chapters:
- A revised chapter titled, “Patient Record and Confidentiality Laws,” updated by Kevin McCaslin, Director, Privacy & Security and Manager of Compliance Reporting at Tenet Healthcare, discusses content and record retention requirements as well as confidentiality requirements under state and federal law, including an overview of HIPAA standards.
- A new chapter titled, “Clinical Research Compliance and Physician Interaction with Research Enterprise,” written by Christopher Goforth, MHA, MPA, CHC and Ryan Meade, JD, CHRC explains the need for health care providers that conduct clinical research to develop compliance initiatives to involve physician-investigators in the compliance process in three areas: undertaking clinical research and contracting, payment, and structural support.
- A new chapter titled “The Importance of Preadmission Screening for Inpatient Rehabilitation Services,” written by Georgeann Edford, RN, MBS, CCS-P discusses the inpatient rehabilitation requirements including the 75% rule, admission criteria, and preadmission screening.
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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
Medicare demonstrations show financial incentives work
Demonstration projects conducted by
CMS provide strong evidence that financial incentives for delivering
quality care increases quality and can reduce the growth in Medicare
expenditures. CMS has announced results from three such demonstrations,
one for large physician practices, one for small and solo physician
practices, and one for hospitals. CMS has also announced the start
of three additional value based purchasing (VBP) demonstrations.
The Hospital Quality Incentive Demonstration (HQID), entering
its fifth year, shows continued quality improvement among its participating
hospitals. Physician practices participating in the Physician Group
Practice (PGP) Demonstration continue to improve quality for patients
with chronic illnesses or requiring preventive care. More than 560
small and solo physician practices participating in the Medicare Care
Management Performance (MCMP) Demonstration are being rewarded for
providing high quality care in the delivery of preventive care and
care for chronic disease patients.
New VBP demonstrations. The VBP initiative is designed
to tie Medicare payments to performance as part of an effort to transform
Medicare from passive payer to active purchaser. The new VBP demonstration
programs include: (1) the Nursing Home Value-Based Purchasing (NHVBP)
Demonstration, (2) the Medicare Hospital Gainsharing (MHG) Demonstration,
and (3) the Physician Hospital Collaboration (PHC) Demonstration.
The NHVBP demonstration program will reward facilities that can improve
or deliver high quality care in the areas of staffing, resident outcomes,
avoidable hospitalizations and reductions in deficiency citations.
The MHG and PHC demonstrations will evaluate whether gainsharing leads
to improvements in quality and efficiency.
Information on value-based purchasing demonstrations is available
at http://www.cms.hhs.gov/DemoProjectsEvalRpts/MD/list.asp
CMS News Release, Aug. 17, 2009
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State agency subsidy of Part D copayments permissible, OIG
A proposed arrangement under which
a state agency would subsidize copayments for outpatient prescription
drugs owed by financially needy Medicare Part D enrollees would not
constitute grounds for the imposition of civil money penalties or
administrative sanctions, according to the Office of Inspector General
(OIG). The state agency functions as the planning agency for alcohol,
drug addiction, and mental health services.
Facts. Under the arrangement, if a patient is eligible
for Medicare Part D, an independent mental health center (“center”)
contracting with the state agency would determine whether the individual
is financially eligible for a Part D copayment subsidy. A patient
would be eligible for a Part D copayment subsidy if eligible, on the
basis of income and if not a Medicare beneficiary, for subsidized
services from the center. If a patient is eligible, the center would
inform him or her that the center would pay part or all of the copayment
to the pharmacy of the patient’s choice for Part D covered medications.
The copayment subsidy would not be advertised. When a Medicare beneficiary
enrolled in Part D takes a prescription to be filled, the pharmacy
bills the beneficiary’s Medicare drug plan for the cost of the
prescription less the applicable copayment. The pharmacy would then
bill the center for the copayment subsidy amount. Funds for the copayment
subsidies would be provided by the state agency to the centers. These
funds could not be used for any other purpose and at the end of the
fiscal year, any amounts not used for copayment subsidies would be
returned to the agency. The subsidy payment is not contingent on a
beneficiary’s choice of any particular Part D plan.
Analysis. Here, the state agency would provide
something of value (Part D copayment) to the federal health care program
beneficiary. The risk is low, however, that this remuneration would
influence the beneficiary to choose any particular provider, practitioner,
or supplier because: (1) the copayment subsidy would not be advertised,
the beneficiary would be screened for eligibility by the center, and
at that time, the beneficiary would have already selected the center
as a provider; (2) while the provider may assist the beneficiary in
enrolling in a Part D plan, the subsidy is not contingent upon the
selection of any particular Part D plan; and (3) payment of the copayment
subsidy is not contingent upon the use of any particular pharmacy.
OIG Advisory Opinion, No. 09-12, Aug.
7, 2009, Health Care Compliance Reporter, ¶500,217
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OIG allows hospital to subsidize affiliated ambulance cooperative
A proposed arrangement under which
a hospital would subsidize an affiliated ambulance cooperative to
enable the cooperative to provide certain ambulance services currently
provided by the hospital would not constitute grounds for the imposition
of civil money penalties or administrative sanctions, according to
the Office of Inspector General (OIG). The acute care hospital provides
various services, including advanced life support (ALS) services,
and is the only hospital in its county that has “comprehensive”
emergency services capability. The hospital is part of a nonprofit
health system, of which the ambulance cooperative is also a member.
The cooperative provides ambulance services in the town and surrounding
communities. Its members include the hospital and several local volunteer
fire companies.
Facts. Under the current arrangement, when the
cooperative's basic life support (BLS) ambulance is dispatched together
with the hospital's paramedic squad, the cooperative bills the ALS
rate, but the hospital does not bill; the cooperative bills the ALS
rate when the ALS portion of the ambulance service actually is provided
by the hospital paramedic squad, because the cooperative and the hospital
are both members of the health system and subject to the health system’s
global budget. As a result of this and other billing practices, the
hospital recoups only half of the cost of providing ALS services through
Medicare and other payers. In contrast, under the proposed arrangement,
responsibility for providing the ALS services provided by the hospital
and the BLS services provided by the cooperative would be consolidated
in the cooperative.
Analysis. The proposed arrangement would continue
an essential service to the community—ALS ambulance services—currently
provided by the hospital at a financial loss. The risk of kickback
abuse from the proposed arrangement is low because: (1) the cooperative
and its members would receive no benefit from the proposed arrangement;
(2) the hospital's donations to the cooperative would not vary with
the volume or value of referrals to the hospital by the cooperative;
(3) the cooperative and the volunteer fire companies are not in a
position to affect referrals in a significant way; and (4) any risk
posed by the proposed arrangement is offset by the fact that there
are no for-profit ambulance services in the county, given the expense
of operating an ambulance service in a sparsely-populated area, and
the fact that ALS ambulance services cannot be provided unless subsidized
by the hospital.
OIG Advisory Opinion, No. 09-13, Aug.
11, 2009, Health Care Compliance Reporter, ¶500,218
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CMS offers guidelines regarding electronic health records
HHS and CMS support the use of electronic
health records (EHR), and their goal is that by 2014 most Americans
will have access to health care providers who use EHRs. The benefits
of EHRs include better patient care, and reduced costs to providers,
Medicare and Medicaid. Presently, providers are permitted to use any
system of medical records that best suit their needs, including paper
and/or electronic systems.
State survey agencies are responsible for enforcing various
conditions of participation (CoPs), conditions for coverage, or conditions
for certification (CfCs). Toward that end, providers must grant access
to any medical record when requested by a surveyor. Surveyors must
establish with the facility the process they will follow to have unrestricted
access to the medical records. If a surveyor requests access to an
EHR, the facility must, among other things, provide the surveyor with
a tutorial on how to use its particular electronic system, and designate
an individual who will, upon request, assist the surveyor in accessing
the electronic information. The facility must also be able to provide
a paper copy of any record, regardless of whether the records are
stored in paper or electronic form. In turn, surveyors should make
reasonable efforts to avoid the printing of entire records, and should
request paper copies of only those records that are necessary to verify
noncompliance, unless protocols require otherwise. Refusing access
to any medical record is a basis for terminating the facility's Medicare
agreement.
While providers are required to maintain the content and confidentiality
of the medical records, surveyors are not expected to review whether
the facility has fulfilled its obligations under the Health Insurance
Portability and Accountability Act. Rather, they should review how
the EHR system is being used, and whether that use is consistent with
the Medicare CoPs or CfCs.
CMS Letter to State Survey Agency Directors, No. S&C-09-53,
Health Care Compliance Reporter, ¶350,173
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$1.2 billion in grants for use of electronic health records
Vice President Joe Biden announced
on August 20, 2009, that nearly $1.2 billion in grants will be available
to (1) help hospitals and health care providers implement and use
electronic health records (EHRs), and (2) help health care providers
qualify for new incentives that will be made available in 2010 for
doctors and hospitals that meaningfully use EHRs. According to HHS
Secretary Kathleen Sebelius, “[EHRs] can help reduce medical
errors, make health care more efficient and improve the quality of
medical care for all Americans.”
The grants, which would be funded by the American Recovery and
Reinvestment Act of 2009, include: $598 million to establish approximately
70 Health Information Technology Regional Extension Centers, which
will provide hospitals and clinicians with hands-on technical assistance
in the selection, acquisition, implementation, and meaningful use
of certified EHR systems; and $564 million to states and Qualified
State Designated Entities to support the development of mechanisms
for information sharing within a nationwide system of networks.
The grants for the Regional Extension Centers will be awarded
on a rolling basis, with the first awards being issued in fiscal year
2010. The grants for states will be issued in fiscal year 2010. Interested
grant applicants can visit http://HealthIT.HHS.gov for more
information.
HHS will also provide additional assistance to health care providers
through the Health Information Technology Research Center, which will
gather relevant information on effective practices from a wide variety
of sources across the country, and help the Regional Extension Centers
collaborate with one another and with relevant stakeholders to identify
and share best practices in EHR adoption, effective use, and provider
support.
CCH Chicago Bureau, Aug. 20, 2009
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On The Front Lines
Tightening Rules May Loosen Relationships Between Manufacturers and Physicians
by Jeff Miller, J.D.
Manufacturers and physicians around the world strive
to provide the highest quality health care products and services to
their patients. Relationships between these manufacturers and physicians
often include financial arrangements that both facilitate and enhance
the quality of medical products and devices and the delivery of high
quality patient care services. While well-structured financial relationships
support the best patient care, many view manufacturers’ financial
support suspiciously, warning that it can inappropriately influence
physicians’ relationships with individual manufacturers and
their views of products’ uses.
In June, 2005 Senators Max Baucus (D-Mont.) and Charles Grassley
(R-Iowa), Chairman and Ranking Member of the Senate Committee on Finance,
began formal inquiries of the twenty-three largest drug manufacturers
in the U.S. following allegations that they were utilizing educational
grants to promote off-label uses for their medications.
This past April, the U.S. Senate Committee on Finance released
a committee staff report to the Chairman and Ranking Member on the
use of educational grants by pharmaceutical manufacturers. In the
report, the committee staff concluded that while the pharmaceutical
industry is paying increased attention to its compliance with federal
law, some CME events, and their associated physicians, are still improperly
influenced by industry sponsors. Supporting its conclusions, the report
cited several specific instances of improper influence, including
a 2004 instance in which Warner-Lambert paid $430 million to settle
allegations that it funded purportedly independent educational events
to promote its anti-epilepsy drug, Neurotin, for off-label uses, and
a 2005 instance in which Serono Laboratories paid $704 million to
settle allegations that it engaged in the same improprieties related
to its drug, Serostim. Both pharmaceutical and medical device investigations,
prosecutions and settlements continue to this day.
Manufacturers and physicians around the world strive to provide
the highest quality health care products and services to their patients.
Relationships between these manufacturers and physicians often include
financial arrangements that both facilitate and enhance the quality
of medical products and devices, and the delivery of high quality
patient care services. The U.S. Government, professional associations
and industry groups continue to focus on these important relationships
to ensure that they facilitate the best quality patient care.
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