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HEADLINES
Wednesday, September 9, 2009

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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Health Care Compliance Professional’s Manual Highlights

Reimbursement Advisor

    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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Receivables Report

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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