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HEADLINES
Wednesday,
June 16, 2010
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On
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The CCH HIPAA Privacy Guide June 2010 update includes:
- Requirements for the Department of Health and Human Services under the Patient Protection and Affordable Care Act (PPACA) to support the use of health information technology (HIT), including (1) integrating the respective reporting mechanisms for the Medicare Physician Quality Reporting Initiative (PQRI) and the electronic health record (EHR) meaningful use incentives no later than January 1, 2012 and (2) establishing standards and operating rules for typical electronic transactions between insurers and providers;
- Two programs for certifying technology for EHR modules proposed by the Office of the National Coordinator (ONC) for Health Information Technology;
- A message from the director of the ONC describing progress in establishing a Nationwide Health Information Network for exchange of health information;
- An OCR chart summarizing key features of about 50 federal laws and regulations addressing “Confidentiality, Privacy and Security."
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Health Care Compliance Professional’s Manual Highlights
Endorsed by the Health Care Compliance Association, the Health Care Compliance Professional’s Manual and written by HCCA board members and other experienced compliance practitioners, provides insights on legislative and regulatory matters, offers guidance on applying the laws and regulations, and includes practical compliance solutions. Report 24 (June 2010), includes the following revised chapters:
- “Health Care Fraud and Abuse Laws,” updated by Ritu Kaur Singh, Esq. reflects recent enforcement activities and changes to the law mandated by the Fraud Enforcement Recovery Act of 2009 and the Health Information Technology for Economics and Clinical Health Act.
- “False Claims Act and Qui Tam Suits,” updated by Ritu Kaur Singh, Esq., reflects recent activity and changes to the law mandated by the Fraud Enforcement Recovery Act of 2009 and the Patient Protection and Affordable Care Act.
- “An Overview of Federal Antitrust Laws and Enforcement Policies,” revised by Bevin M.B. Newman, JD., updates discussions of antitrust laws and adds recent antitrust enforcement actions related to the health care industry.
- “Developing, Delivering, and Positioning Compliance Education and Training,” updated by Donnetta Horseman, MA, CHC, CIPP, CCE, provides additional information on training staff, including tips and examples.
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Headlines
First state-specific healthcare-associated infection report available
A new report from the Centers for
Disease Control and Prevention’s (CDC) National Healthcare Safety
Network (NHSN), the first in a series, represents the first time that
the CDC has reported state-specific healthcare-associated infection
(HAI) information. The initial report, titled “The
First State-Specific HAI Summary Data Report,” includes both
national central line-associated bloodstream infection (CLABSI) data
and state-specific data for states mandated by state law to report
CLABSIs. Using new data from CDC’s NHSN, the report shows an
18 percent decrease in national CLABSI incidence. It is hoped that
future reports will include other infection types and data from all
states. Composite statistics used. The report
presents composite statistics summarizing HAI data available from
NHSN at the national and state levels. The HAI data reported are limited
to CLABSIs. The CLABSI data are summarized using the Standardized
Infection Ratio (SIR), a statistic used to measure the relative difference
in HAI occurrence during a reporting period compared to a common referent
period (i.e., standard population). The SIR can be used to track HAIs
at the national, state, and local levels over time, and is closely
related to the Standardized Mortality Ratio (SMR), a summary statistic
widely used in public health to analyze mortality data. In HAI data
analysis, the SIR compares the actual number of HAIs in a facility
or state with the baseline U.S. experience (i.e., standard population),
adjusting for several risk factors that have been found to be most
associated with differences in infection rates. Results. The
results of the report are summarized in three tables:
- Table 1 summarizes the variability and extent of state
HAI reporting to NHSN for CLABSIs. Data were reported in 47 states
and Washington, D.C. States with reporting mandates for CLABSI provided
the most data; however, in many instances a large number of facilities
reported data in states without mandates.
- Table 2 displays (1) state-specific CLABSI SIRs for those
states with a mandate for reporting CLABSI data, and (2) SIRs for
the national aggregate data. Eleven of the 17 states with a state
mandate to report CLABSI had SIRs significantly less than 1.0, while
only two had SIRs significantly higher than 1.0. Nationally, among
1,538 facilities reporting CLABSI data to NHSN during the reporting
period, 4,615 CLABSIs were reported. This is estimated to be 18 percent
fewer than predicted, resulting in an SIR of 0.82 (95 percent CI 0.80
- 0.85).
- Table 3 shows key percentiles within the distribution
of the CLABSI SIRs calculated at the facility level within each state.
During this first reporting period, in nearly all of the states with
a mandate for CLABSI, at least 25 percent of healthcare facilities
reported zero CLABSIs.
CDC’s First State-Specific
Healthcare-Associated Infections Summary Data Report, January
- June, 2009, May 27, 2010.
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Part D coverage gap discount, draft model manufacturer agreement issued
A draft model agreement to be used
by the Secretary of the Department of Health and Human Services (HHS)
and prescription drug manufacturers in implementing the Medicare Coverage
Gap Discount Program (Discount Program) has been issued by the Centers
for Medicare & Medicaid Services (CMS). Comments on the draft
model agreement must be submitted to CMS by June 21, 2010. Statutory
authority. Section 3301 of the Patient Protection and Affordable
Care Act (PubLNo 111-148), as amended by §1101 of the Health
Care and Education Reconciliation Act of 2010 (PubLNo 111-152) (collectively
known as the Affordable Care Act), established the Discount Program
by adding §1860D-43 and §1860D-14A to the Social Security
Act. Program requirements. Effective January
1, 2011, the Discount Program will make manufacturer discounts available
to applicable Medicare beneficiaries receiving applicable covered
Part D drugs while in the coverage gap. In general, the discount on
each applicable covered Part D drug is 50 percent of an amount equal
to the negotiated price. Also, beginning January 1, 2011,
a Part D drug will only be covered under Part D if the manufacturer:
has a signed agreement with the Secretary to participate in the Discount
Program, provides applicable discounts on coverage gap claims for
all of its applicable drugs, and remains in compliance with the terms
of the agreement. The requirement applies to manufacturers of applicable
Part D drugs. The Secretary, however, reserves the right to require
all manufacturers to sign the agreement in the future if it is discovered
that access to applicable Part D drugs is restricted. CMS also encourages
manufacturers of non-applicable drugs to enter into an agreement if
they intend to manufacture applicable Part D drugs in the future. The
new law also permits CMS to allow coverage of drugs not covered under
an agreement if it determines that availability of the drug is essential
to the health of beneficiaries or, for 2011 only, if there are extenuating
circumstances. CMS, however, does not intend to apply this authority
as it expects all manufacturers of applicable drugs to sign the agreement
so that there will be no changes in the availability of coverage for
Part D drugs. CMS plans to notify the public as early as possible
if certain manufacturers fail to sign the agreement. No
individual revision of agreement. CMS intends to use the model
manufacturer agreement as a standard agreement that will not be subject
to further revision based on negotiations with individual manufacturers.
The model manufacturer agreement will be finalized and posted on the
CMS Web site after CMS has considered the public comments and consulted
with manufacturers. CMS Notice,
75 FR 29555, May 26, 2010, Health Care Compliance Reporter.
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Patient referral program, patient assistance program not sanctionable, OIG
The Office of Inspector General (OIG)
recently concluded that neither a referral rewards program nor a patient
assistance program would constitute grounds for sanctions under the
civil monetary penalty provision or the exclusion authority of the
Social Security Act. Referral rewards program. An
operator of several continuing care retirement communities (CCRCs)
that provided housing and services to the elderly proposed a rewards
program for current residents and employees. The proposed rewards
program consisted of two parts: (1) gift cards to current residents
and employees who recommended their community to a prospective resident,
and (2) credits or rewards to current residents or employees if the
prospective resident moved into independent living at the CCRC. The
OIG determined that the proposed program would have no impact on any
health care professional’s decision to order a health care item
or service or to refer a patient to a particular provider or supplier,
and concluded that the referral program would not generate prohibited
remuneration under the anti-kickback statute. The CCRC operator did
not provide health care services nor did it participate in federal
health care programs. When residents at the independent living level
of care needed health services or items, they accessed them independently
from outside providers or suppliers. Whether an individual
resident referred by a current resident or employee would actually
end up needing federal health care programs at some point in the future
was substantially speculative and outside the control of the current
resident or employee. Patient assistance program. A
non-profit, charitable corporation operated a patient assistance program
that offered financial help with co-payments to patients, including
Medicare beneficiaries covered by Medicare Part B, Medicare Part D,
Medicare Supplementary Health Insurance (Medigap), and Medicare Advantage. The
corporation solicited funding from donors, such as individuals and
pharmaceutical manufacturers, and had absolute, independent, and autonomous
discretion as to the use of the contributions within a disease fund.
No donor exerted any direct or indirect influence or control over
the corporation. The OIG concluded that the program would
not constitute grounds for the imposition of civil monetary penalties
and that, while the program could potentially generate prohibited
remuneration under the anti-kickback statute if the requisite intent
to induce or reward referrals of federal health care program business
were present, the OIG would not impose administrative sanctions. OIG
Advisory Opinions, Nos. 10-05 and 10-06, May 19 and 20, 2010,
Health Care Compliance Reporter.
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Conviction affirmed for fraudulent billing services company
An owner of a company that provided
billing services to medical providers for Medicare and other health
insurance plans was properly convicted and sentenced on three counts:
(1) conspiracy to defraud the U.S. and to pay and receive health care
kickbacks in violation of 18 U.S.C. §371; (2) conspiracy to commit
health care fraud in violation of 18 U.S.C. §1349; and (3) conspiracy
to launder money in violation of 18 U.S.C. §1956(h). Fraudulent
billing scheme. One of the clients of the company was a medical
clinic, which was later purchased by the owner’s close friends
with the financial assistance of the owner. Prior to the sale, the
medical clinic billed Medicare less than $26,000 and received slightly
more than $10,000. Two weeks after the sale, the clinic billed Medicare
over $262,000, and received $125,000. Patients were given cash payments
known as "candy" each time they went to the clinic, regardless
of whether they received treatment. The clinic completed "superbills," which
were billing forms used by providers containing patient information
and diagnostic codes for submission to Medicare/Medicaid and insurance
companies. The superbills always indicated that a patient received
treatment, even when the patient was not treated. Sufficiency
of the evidence. Contrary to the owner’s argument, the
government presented more than enough evidence to establish the owner’s
convictions: the sudden increase in billing after the owner’s
close friends purchased the medical clinic, and the inflated expenses
listed on the superbills. Further, there was a tape recording of the
owner telling an employee of the medical clinic that the clinic had
paid kickbacks to patients and that the owner was behind the whole
scheme. The owner’s remaining arguments either were
waived on appeal or were meritless. U.S.
v. Sotto, 11th Cir., May 26, 2010, Health Care Compliance
Reporter.
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On The Front Lines
National Health Emergencies Response: Federal Statutes and Regulations, Part 2
by Patricia L. Brent, J.D., M.P.H.
This is Part 2 of a two-part article on federal statutes
and regulations that allow flexibility or modification of statutory
requirements for healthcare providers during times of national disasters
or public health emergencies, such as the H1N1 influenza pandemic
of 2009/2010. Part 1 of the article, which appeared in the June 1,
2010 issue (Vol. 13-11), discussed the National Emergencies Act (NEA),
the Robert T. Stafford Disaster Relief and Emergency Assistance Act
(Stafford Act), the Pandemic and All-Hazard Preparedness Act and Section
1135 waiver (§1135) of the Social Security Act. President
Obama declared the 2009 H1N1 influenza pandemic to be a national emergency
under the NEA on October 23, 2009. This proclamation was aimed at
providing HHS with the ability to waive certain legal requirements
that might otherwise hinder the ability of our nation’s healthcare
system to respond to a surge in patients that might occur as a result
of the H1N1 influenza outbreak. On April 26, 2009, the acting HHS
Secretary declared a public health emergency in response to the H1N1
outbreak, and HHS Secretary Sebelius renewed that declaration on July
24, 2009, and again on October 1 and December 29. The President’s
proclamation, along with the declaration of a public health emergency
made by the HHS Secretary, allowed for the waiver of sanctions under §1135,
which were invoked on October 29, with a retroactive effect to October
23, 2009. The Secretary delegated to CMS the decisions to which requirements
could be waived and for which providers. Hospitals and clinics in
the affected areas where H1N1 influenza outbreaks were most prevalent
during the declared public health emergency were then able to apply
for a §1135 waiver if they had a demonstrable need for such. Within
a panoply of federal statutes and healthcare regulations there exists
a body of coordinated policies and procedures that provide flexibility
for hospitals that must respond to national health emergencies, such
as the H1N1 influenza pandemic of 2009/2010, or natural disasters,
such as Hurricane Katrina or the North Dakota floods of 2009 and 2010.
While these regulations have specific requirements that must be met,
they provide a hospital with needed options for ensuring that appropriate
care can be delivered even during the most stressful of disaster events
without risking normal sanctions imposed for non-compliance. Note:
Portions of this article were excerpted from Emergency Department
Reimbursement Manager, 2010 Edition, Medical Learning, Inc.,
St. Paul, MN. Reprinted with permission.
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