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HEADLINES
Wednesday, July 28, 2010

CCH® Health Care Compliance Integrated Library
The Health Care Compliance Integrated Library delivers the latest information on health law. The Library includes seven invaluable titles:
  • Civil False Claims and Qui Tam Actions - An essential tool for bringing or defending Qui Tam action.
  • Clinical Research Compliance Manual: An Administrative Guide - Essential guidance on the laws and regulations affecting clinical research and trials.
  • Defending and Preventing Health Care Fraud and Abuse Cases: An Attorney's Guide - Clear, expert guidance on protecting against charges of health care fraud and abuse.
  • Health Care Fraud and Abuse Compliance Manual - Giving health care providers a clear perspective on fraud and abuse laws, written in plain-language.
  • Health Law and Compliance Update - Find the latest information on emerging issues. Each section is authored by an expert in the area and includes in-depth analysis of the latest health law and compliance issues.
  • Hospital Contracts Manual - Expert, current know-how in dealing with numerous hospital contract scenarios.
  • Hospital Law Manual - Health Law expertise covering treatment and payment issues in the delivery of health care services.

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Journal of Health Care Compliance July/August Volume 12, Number 4:

Reimbursement Advisor

    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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Receivables Report

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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