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HEADLINES
Wednesday,
July 28, 2010
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On
The Front Lines
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Journal of Health Care Compliance July/August Volume 12, Number 4:
In addition to regularly featured columns such as electronic resources, HIPAA, best practices, coding and billing, and physician compliance, the July/August 2010 issue of the Journal of Health Care Compliance includes the following articles:
- State Offices of Medicaid Inspector Generals: Implications for Medicaid Fraud Enforcement, written by Jack Wenik, discusses the trend toward state Offices of Medicaid Inspector Generals, the implications for self-reporting and anti-fraud and waste efforts, and their effect on compliance programs.
- The Health Care Reform Bill: Compliance Implications for Behavioral and Mental Health Services, written by Dinh Nguyen, discusses the changes in the behavioral and mental health services climate and proactive approaches that can be taken to mitigate potential exposure to increasing regulatory liability.
- Medicaid Integrity Program - What You Need to Know, written by Joanne B. Erde, provides an overview of what to expect from a Medicaid Integrity Audit, including the establishment of a Medicaid Integrity Program (MIP) and how the MIP process works: from data review, through the audit, to recoupment.
- Medication Management for Medical Practices and Physicians, written by D. Scott Jones, discusses the prevalence of medication errors; how Medicare Part D has increased the focus on the prescribing practices and utilization of doctors; and additional regulatory scrutiny regarding CDC vaccine management guidelines, OSHA bloodborne pathogen standards, and FDA labeling requirements.
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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
Rules supporting “meaningful use” of electronic health records announced
Final rules designed to help improve
Americans’ health, increase safety, and reduce health care costs
through expanded use of electronic health records (EHRs) have been
announced by HHS Secretary Kathleen Sebelius. A final rule from CMS
describes the Medicare and Medicaid program incentives for meaningful
use of EHRs, and a final rule from the HHS Office of the National
Coordinator for Health Information Technology (ONC-HIT) specifies
the technical standards for certified EHR technology. Both final rules
will be published in the Federal Register on July
28, 2010. The regulations will be effective 60 days after publication
in the Federal Register.
The CMS final
rule implements provisions of the American Recovery and Reinvestment
Act of 2009 (ARRA) (P. L. 111-5) that provide incentive payments to
eligible professionals (EPs), eligible hospitals and critical access
hospitals (CAHs) that adopt and successfully demonstrate meaningful
use of certified EHR technology.
The final rule specifies:
(1) the initial criteria EPs, eligible hospitals, and CAHs must meet
in order to qualify for an incentive payment; (2) the calculation
of the incentive payment amounts; (3) payment adjustments under Medicare
for covered professional services and inpatient hospital services
provided by EPs, eligible hospitals, and CAHs failing to demonstrate
meaningful use of certified EHR technology; and (4) other program
participation requirements.
These Medicare and Medicaid
incentive payments are part of a broader effort under the Health Information
Technology for Economic and Clinical Health (HITECH) Act, which was
adopted as part of the ARRA economic stimulus legislation in 2009,
to accelerate the adoption of HIT and utilization of qualified EHRs
by healthcare providers. As much as $27 billion over ten years will
be expended to support adoption of EHRs.
The proposed
rule, published on January 13, 2010 (75 FR 1844, Health Care Compliance
Reporter, ¶730,079),
described the new set of regulations that will be adopted under the
final rule, "Standards For The Electronic Health Record Technology
Incentive Program" (42 C.F.R. Part 495), along with amendments
to regulations related to payments to hospitals, CAHs and MA organizations.
Requirements
for meaningful use incentive payments will be implemented over a multi-year
period, phasing in additional requirements that will raise the bar
for performance on IT and quality objectives in later years.
HHS Press Release, Fact Sheet, and Federal Register Advance
Publications, July 13, 2010.
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Announcing the New CCH Health Reform Toolkit
In response to the new health reform laws—Patient Protection
and Affordable Care Act and Health Care and Education Reconciliation
Act of 2010—Wolters Kluwer introduces the CCH Health Reform
Toolkit, a complete suite of electronic workflow tools for navigating
the nearly 3,000 pages of legislation through easy-to-understand topics
related to the hospital, pharmaceutical, and legal industries.
The
Toolkit will further keep you abreast of all future Health Reform
impact by automatically tracking related amended regulations, rules,
new legislation, and primary source documents, providing access to
full text documents and weekly email notifications so that you can
keep on top of all guidance and changes that the government agencies
release.
The CCH Health Reform Toolkit is available with
links to the CCH Medicare and Medicaid Guide laws, regulations and
explanations, incorporating industry trusted content with new workflow
tools; or as a stand-alone product incorporating the e-version of
the CCH Law, Explanation & Analysis book on these health reform
laws.
To learn more about the CCH Health Reform Toolkit,
please go to http://health.cch.com/Products/Health-Reform-Toolkit.asp;
or contact your local sales rep at 888-224-7377.
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SNF’s noncompliance with hydration policy puts resident in immediate jeopardy
CMS correctly imposed an immediate
jeopardy-level civil monetary penalty and a denial of payment for
new admissions on a skilled nursing facility (SNF) for failing to
notify a resident’s physician and family when a significant
change occurred in his condition and for failing to provide each resident
with sufficient fluid intake to maintain proper hydration and health,
according to the U.S. Court of Appeals, Sixth Circuit. Additionally,
the Sixth Circuit found that it was not arbitrary or capricious for
an administrative law judge to conclude that it would only review
those deficiencies that had a material impact on the outcome of the
dispute, in the interests of judicial economy.
While
the SNF argued that there was not a "significant change" in
the resident’s condition (see 42 C.F.R. § 483.10(b)(11)),
substantial evidence supported the finding of fact that a substantial
change had occurred in the resident’s physical condition when
he lost 18.5 pounds over a three-week period, which triggered the
regulatory obligation to notify the resident’s physician and
family. The SNF argued against the finding of a significant change
because the Department Appeals Board did not refer to a specific date
or benchmark when such a change would have occurred.
Federal
law requires SNFs to "provide each resident with sufficient
fluid intake to maintain proper hydration and health" (see 42 C.F.R. §483.25(j)), and the SNF failed to substantially comply with
this regulation by not following its own hydration policies, the court
stated. Even though the regulations did not specifically require the
SNF’s procedure of calculating resident hydration needs, once
a facility chooses a method of assuring sufficient fluid intake, a
CMS surveyor is permitted to rely on that chosen method as its standard
of compliance, according to the court. Substantial evidence showed
that the SNF’s staff was not knowledgeable of or compliant with
the facility’s hydration monitoring policies and procedures.
Claiborne-Hughes
Health Center v. Sebelius, 6th Cir., June 25, 2010.
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Council begins developing national health strategy
The 2010 Annual Status Report of the National Prevention, Health
Promotion and Public Health Council establishes guiding principles,
member responsibilities, data on leading causes of death, and possible
interventions. The council was created by the Patient Protection and
Affordable Care Act (PPACA) (P.L. 111-148). The strategy is to establish
actions within and across federal departments and agencies relating
to prevention, health promotion, and public health. PPACA required
the submission of this report to the president and Congress by July
1, 2010.
The strategy will prioritize evidence-based policy
and program interventions intended to meet measurable goals related
to the leading causes of death and disability and the factors that
underlie these causes, including tobacco use, obesity, poor nutrition,
physical inactivity, and excessive alcohol use.
The development
of the strategy will be based on a set of guiding principles that:
(1) makes prevention and wellness a priority, (2) focuses on preventing
the leading causes of death and the factors that underlie these causes,
(3) prioritizes high-impact interventions, (4) promotes health equity,
(5) promotes alignment between the public and private sectors, (6)
establishes a cohesive federal response by federal agencies to the
issues identified by the strategy, and (7) ensures accountability.
PPACA specified that the strategy should promote alignment of federal
programs to ensure that they are efficient and grounded in science-based
prevention recommendations.
The report identified five
leading causes of death that contribute to reduced quality of life
and account for nearly two-thirds of all deaths in the United States.
Preventing these causes will result in significant cost savings to
the U.S. health care system and public budgets. The five leading causes
of death are (1) heart disease, (2) cancers, (3) stroke, (4) chronic
lower respiratory disease, and (5) unintentional injuries.
The
council is comprised of Cabinet Secretaries, chairs, directors, or
administrators of federal departments; the Surgeon General serves
as chairperson. An advisory group is to be established within HHS
that assists the council. The council is also directed to engage various
stakeholders for input in developing the strategy. Stakeholders will
include the public; community-based organizations, practitioners and
experts in the public and private sectors who are engaged in prevention
and wellness programs and activities; federal, state, regional, and
local officials engaged in work related to public health; Indian tribes
and tribal organizations; voluntary health organizations; and others
in various sectors that have an impact on the public’s health.
The strategy is expected to be implemented during the first quarter
of 2011.
CCH Chicago Bureau, July
6, 2010.
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Proposed rule modifies civil money penalties for noncompliant nursing homes
A proposed rule released by CMS would
modify the civil money penalties (CMPs) that are imposed on nursing
homes for noncompliance with Medicare conditions of participation.
The Patient Protection and Affordable Care Act (P.L. 111-148), §6111,
amended Social Security Act §1819(h) and §1919(h) to incorporate
specific provisions to improve the efficiency and effectiveness of
the nursing home enforcement process and to address CMPs imposed by
CMS.
The key modifications created by the proposed rule
include: (1) an independent informal dispute resolution process (IDR)
would be made available when a CMP is imposed; (2) after an independent
IDR finds CMP funds need to be collected, the funds would be placed
in escrow account pending completion of any formal appeal; and (3)
a 50 percent reduction of a CMP would be made in certain cases for
prompt correction of self-reported instances of noncompliance.
The
per day CMPs would be effective and continue to accrue, but would
not be collected while the CMP is subject to the independent IDR process.
The collection of the CMP would occur either at the completion of
an independent IDR or 90 days after notice has been given that a CMP
would be imposed, whichever is earlier. When a facility’s formal
appeal is successful, the applicable portion of any CMP amount being
held in escrow will be returned to the facility with interest.
Under
the proposed rule, CMS would have new authority to reduce a CMP by
50 percent when CMS determines a facility has self-reported, promptly
corrected its noncompliance, and waived its right to a hearing. However,
noncompliance that constitutes immediate jeopardy, a pattern of harm,
widespread harm, or results in a resident’s death would not
be eligible for this reduction. Facilities that have repeated noncompliance
for which a penalty reduction under this provision was received during
the previous year would not be eligible for another reduction. A facility
that receives a 50 percent reduction also may not receive the 35 percent
reduction for waiving its right to a hearing under current regulations.
All
comments regarding the proposed rule must be received by 5 p.m. eastern
standard time on August 11, 2010.
Proposed
rule, 75 FR 39641, July 12, 2010, Health Care Compliance
Reporter, ¶730,091.
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On The Front Lines
Medicaid Integrity Program — What You Need to Know
by Joanne B. Erde, PA
The federal Medicaid Integrity Program (MIP) was created
by the Deficit Reduction Act of 2005 and was signed into law in February
2006. The MIP is the first federal program that was established to
combat fraud and abuse in state Medicaid programs. This article discusses
the establishment of MIP, including its infrastructure and functions,
and presents a quick overview of what to expect from a Medicaid Integrity
Audit. Overall, the MIP process will consist of three steps: (1) data
review, (2) the audit, and (3) recoupment.
Congress determined that a federal program
was necessary due to the fact that state Medicaid enforcement efforts
varied wildly from state to state. Also, these variations were frequently
due to the wealth and size of the individual states and the amount
of resources that were available for compliance enforcement for each
state Medicaid program.
As a result, MIP was established
in the hope that it would cause a more uniform and consistent Medicaid
enforcement effort across the states. It is, however, in addition
to and not instead of the existing state enforcement efforts that
are routinely carried out by the various state Medicaid Fraud Control
Units (MFCUs) and the program integrity divisions of the state Medicaid
agencies. Due to the potential for collision and overlap, there is
supposed to be coordination amongst all the enforcement players.
Although
this uniformity of enforcement effort is desirable to the Centers
for Medicare & Medicaid Services (CMS), the fact that it is a
federal program may generate a certain level of legal tension amongst
the parties because of the "misalignment" of the parties involved.
There is a direct legal relationship between the federal government
and the state government. As such, the state Medicaid agency complies
with federal law, and in return the federal government pays the federal
financial participation to the state.
In the Medicaid
context, however, the federal government has no direct relationship
with the provider of Medicaid services. Only the state has the direct
legal relationship with the provider. The provider renders services
pursuant to the state plan and is paid by the state. Because there
is no direct legal relationship between the federal government and
the provider, operational issues potentially may arise over the operation
of MIP, particularly in the recoupment of the alleged overpayments.
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