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HEADLINES
Wednesday, July 14, 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

When “good” people do bad things - check your ethical culture

Will “good” people do bad things if they are put in an environment that does not value ethics? The answer is “yes,” according to the “2009 National Business Ethics Survey (NBES)” conducted by the Ethics Report Center (ERC).

Six times since 1994, the ERC has performed a national poll of employees at all levels, exploring beliefs and experiences related to ethics and compliance. Over time, ERC research has indicated that the strength of a company’s ethical culture drives whether or not employees feel pressure to compromise company standards, the rate of observed misconduct, whether employees who observed misconduct chose to report it, and whether those who report feel retaliated against. Past ERC research has also found that ethical cultures are stronger during times of increased scrutiny, and are perceived differently by different kinds of employees. For example, ERC found that managers, nonunion workers, older workers, and tenured employees perceive a stronger ethical culture within their company; while nonmanagement employees, union workers, younger workers, and recent hires perceive a weaker ethical culture within their company.

Using NBES 2009 data, the ERC found the following:

  • Ethical culture continues to have a profound impact on pressure, observed misconduct, reporting of observed misconduct, and rates of retaliation against reporters.
  • Actions and perceptions of top managers drive the ethical culture of the company and have a significant impact on outcomes.
  • Coworker culture is particularly powerful for decreasing observations of financial misconduct, but top management culture is associated with the greatest increases in reporting it.
  • Although overall culture and coworker culture are on the rise, perceptions of management (top and supervisors) are declining.
  • When it comes to strength of ethical culture, some companies (i.e., publicly traded, highly unionized, and those with more than 500 employees) are at an innate disadvantage.

ERC recommends that senior leaders wishing to improve their companies’ ethical cultures: (1) make developing a strong ethical culture a business priority; (2) lead by example; talk the talk and walk the walk; (3) develop programs that encourage ethics as a priority; (4) be mindful of what challenges are innate to your organization and find ways to help employees feel invested in the company; and (5) invest time in regular assessment and careful analysis.

The ERC survey report, titled “The Importance of Ethical Culture: Increasing Trust and Driving Down Risks,” is available from the Health Care Compliance Association web site at http://www.hcca-info.org.

Ethics Resource Center Report, 2009 National Business Ethics Survey, 2010.

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GAO identifies strategies for CMS to prevent improper payments

The Government Accountability Office (GAO) identified several key strategies for CMS to prevent fraud, waste, and abuse in Medicare. While CMS has made progress in implementing some of the strategies, there is still room for improvement.

One strategy was strengthening the provider enrollment process and standards to reduce the risk of enrolling providers intent on abusing the program. For instance, CMS should perform background checks on providers at the time they apply to become Medicare providers.

A second strategy identified by the GAO was to improve prepayment review of claims by having automated payment controls called "edits" in place that can deny or flag inappropriate claims. The GAO discovered that, despite its prior recommendation to CMS, CMS did not require its contractors to develop thresholds for unexplained increases in billing and use them to develop automated prepayment controls. However, CMS added edits to flag claims for services that were unlikely to be provided in the normal course of medical care.

The GAO’s third strategy was to focus postpayment claims review on the most vulnerable areas, which include HHAs and DMEPOS suppliers. The GAO discovered that CMS did not routinely provide physicians responsible for authorizing home health care with information that would enable them to determine whether an HHA was billing for unauthorized care. It was recommended that CMS direct its recover audit contractors to focus on items and services where contractors were not expected to focus their reviews, and where improper payments were known to be high.

A fourth strategy to combat overpayments was improving oversight of CMS’ contractors. The OIG observed that, while limited, CMS’ oversight of its programs has been expanding. For example, CMS was beginning to, among other things, revise its audit protocol and pilot on-site audits.

Finally, the GAO recommended that CMS develop a robust process for addressing identified vulnerabilities. Specifically, CMS should develop and implement a process to ensure that it promptly: (1) evaluates the findings of recovery audit contractors, (2) decides on the appropriate response and a time frame for taking action, and (3) acts to correct the vulnerabilities identified.

GAO Report, No. GAO-10-844T, June 15, 2010, Health Care Compliance Reporter, ¶570,002.

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"Do Not Pay List" created to ensure payment accuracy

The Obama Administration recently announced the creation of a "Do Not Pay List," a list of databases that federal agencies must review before issuing any payment or award to any recipient. Agencies specifically are required to review current pre-payment and pre-award procedures, and ensure a thorough review of the databases in the "Do Not Pay List" to identify ineligible recipients and prevent certain improper payments from being made in the first place.

Before issuing any payment or award, agencies must, at a minimum, check the following databases from the "Do Not Pay List": the Social Security Administration’s Death Master File; the General Services Administration’s Excluded Parties List System; the Department of the Treasury’s Debt Check Database; the Department of Housing and Urban Development’s Credit Alert System or Credit Alert Interactive Voice Response System; HHS’ Office of Inspector General’s List of Excluded Individuals/Entities; and any additional databases designated by the Director of the Office of Management and Budget (OMB) in consultation with agencies.

The Obama Administration began coordination of the databases in April 2010 by launching the Federal Awardee Performance and Integrity Information System. The Director of the OMB is required to provide a plan for completing integration for the remaining databases, to the extent permitted by law, to enable agencies to access them through a single entry point. Each agency is required to submit to the OMB: (1) a plan that includes information on its current pre-payment and pre-award procedures, and (2) a list of databases that the agency checks pursuant to those procedures.

The Director of the OMB is then required to issue guidance on actions agencies must take to carry out the Administration’s initiatives on payment accuracy. This guidance must: (1) clarify that the head of each agency is responsible for ensuring an efficient and accurate process for determining whether the information provided on the "Do Not Pay List" is sufficient to stop a payment, and, if so, whether a payment should be stopped under the circumstances; and (2) identify best practices and databases that agencies should utilize to conduct pre-payment checks to ensure that only eligible recipients receive government benefits or payments.

Memorandum for the Heads of Executive Departments and Agencies, June 18, 2010.

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Temporary testing and certification program established for electronic health records

A temporary certification program for testing and certifying health information technology has been implemented by the Department of Health and Human Services (HHS). The program is established under the authority granted to the National Coordinator for Health Information Technology by §3001(c)(5) of the Public Health Service Act (PHSA), as added by the Health Information Technology for Economic and Clinical Health (HITECH) Act.

Program purpose. The National Coordinator will utilize the temporary certification program to authorize organizations to test and certify Complete Electronic Health Records (EHRs) and/or EHR Modules, thereby making Certified EHR Technology available prior to the date on which health care providers seeking incentive payments available under the Medicare and Medicaid EHR Incentive Programs may begin demonstrating meaningful use.

The temporary certification program provides a process by which an organization or organizations may become an Office of National Coordinator–Authorized Testing and Certification Body (ONC–ATCB) and be authorized by the National Coordinator to perform the testing and certification of Complete EHRs and/or EHR Modules.

Application process. Under the temporary certification program, the National Coordinator will accept applications for ONC–ATCB status at any time. In order to become an ONC–ATCB, an organization or organizations must submit an application to the National Coordinator to demonstrate its competency and ability to test and certify Complete EHRs and/or EHR Modules. An applicant will need to be able to both test and certify Complete EHRs and/or EHR Modules.

HHS anticipates that only a few organizations will qualify and become ONC–ATCBs under the program. These organizations will be required to remain in good standing by adhering to the Principles of Proper Conduct for ONC–ATCBs. ONC–ATCBs will also be required to follow the conditions and requirements applicable to the testing and certification of Complete EHRs and/or EHR Modules as specified by HHS in its final rule.

Sunset. The temporary certification program will end on December 31, 2011, or if the permanent certification program is not fully constituted at that time, then upon a subsequent date that is determined to be appropriate by the National Coordinator.

HHS Final Rule, 75 FR 36158, June 24, 2010, Health Care Compliance Reporter, ¶700,259.

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Nontraditional “family” hospital visitation rights proposed

Hospitals participating in Medicare and Medicaid and critical access hospitals (CAHs) would be required to allow the visitation of loved ones and close friends who provide comfort and support to the patient, but do not fit into the traditional concept of “family,” under a proposal issued by the Centers for Medicare & Medicaid Services (CMS).

Under the CMS proposal, participating hospitals and CAHs would be required to have written policies and procedures regarding the visitation rights of patients, including those setting forth any clinically necessary or reasonable restriction or limitation that the hospital or CAH may need to place on such rights as well as the reasons for the clinical restriction or limitation.

The policies and procedures would require the hospitals or CAHs to: (1) inform each patient (or representative) of his or her visitation rights, including any clinical restriction or limitation on such rights; (2) inform each patient (or representative) of the right to receive the visitors whom he or she designates, including, but not limited to, a spouse, a domestic partner (including a same-sex domestic partner), another family member, or a friend, and his or her right to withdraw or deny such consent at any time; (3) not restrict, limit, or otherwise deny visitation privileges on the basis of race, color, national origin, religion, sex, sexual orientation, gender identity, or disability; and (4) ensure that all visitors designated by the patient (or representative) enjoy visitation privileges that are no more restrictive than those that immediate family members would enjoy.

To be assured consideration, comments on the proposed rule must be received by August 27, 2010.

CMS Proposed Rule, 75 FR 36610, June 28, 2010.

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On The Front Lines

Healthcare Employers Under Attack: The Rise of Wage and Hour Class Action Lawsuits

by William Schurgin, Kristin McGurn and Noah Finkel

The use of best practices and the regular review of wage and hour practices is an important part of the healthcare employers' legal compliance strategy. This is particularly true given the rise in wage and hour litigation against healthcare employers, increased enforcement efforts by the Department of Labor in certain metropolitan areas, and the aggressive tactics of plaintiffs' counsel in these actions. This article surveys these recent wage and hour actions, discusses possible employer defenses, and provides compliance-related recommendations which will serve to prepare employers for potential litigation.

In light of the growing number of wage and hour lawsuits against healthcare employers, it is recommended that every employer review its wage payment practices. While the DOL has indicated that it is not unlawful for healthcare employers to use timekeeping systems that deduct time for meal breaks, these complaints illustrate the importance of taking steps — even though not legally required — to reduce the likelihood of becoming a target in such a suit as well as to provide good defenses in the event of such litigation.

Healthcare employers should periodically review wage and hour policies and pay practices in all areas including meal periods and work performed before and after a scheduled shift. Hospitals should also actively open lines of communication with employees about meal break policies including the importance of taking full meal breaks, the means by which interrupted or missed breaks must be reported so that they can be compensated, and the critical responsibility employees have for following complaint procedures to bring any perceived problems promptly to the attention of the employer. Regular training of employees and managers on topics such as certification of time worked and receipt of meal breaks, accurate time recording, exception reporting, and deduction overrides are another important element of any compliance program.

Given the increased level of activity in wage and hour litigation, not to mention the increased focus on enforcement by the DOL, looking to industry best practices and regularly reviewing wage and hour practices in every area should be an important part of every healthcare employers’ legal compliance strategy. This is an area that will continue to foster litigation and government audits in the near future. Accordingly, healthcare employers should stay on top of where these actions are going and make sure that they have appropriate compliance mechanisms in place.

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