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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:

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• 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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Any form of health care reform likely will result in more individuals having some form of insurance coverage. As many as 46 to 47 million uninsured individuals may have insurance coverage under health care reform. With many areas of the country already without sufficient primary care provider capacity, how will the system react? Will the lines at Emergency Departments at hospitals be longer like in Massachusetts after it enacted its own form of health care reform? Will more primary care physicians, like those in San Francisco, seek to be concierge providers further exacerbating the shortage? A likely unintended consequence of health care reform is greater difficulty in accessing primary care services. The concept of every individual in the U.S. having a medical home is laudatory, but just how will this happen when there already is a shortage of primary care capacity? Early retirement by physicians and lack of sufficient nursing school teachers does not help the situation. Compliance officers should be prepared to address many of the unintended consequences that health care reform likely will bring as a result of a probable increasing primary care shortage, including the following:

• Physician recruitment efforts will be much more difficult, particularly in the primary care area. Compliance officers will need to pay particular attention to these relationships and contracts to ensure that they are consistent with applicable law and regulations, as there will be an incentive to “push the envelope” to get the recruit. It will be important to make sure fair market value compensation analyses will keep pace.
• Contracts for emergency department physicians and allied health professionals staffing and/or employment contracts in this area will have to keep pace with the increasing patient loads in emergency departments. Compensation and/or subsidies to physicians likely will have to rise. A greater use of physician extenders will have to be made. Emergency department redesign may be necessary, but where will all the new professionals come from? Compliance officers will have to keep abreast of these newly evolving relationships and whether they are consistent with applicable law and regulations.

Reprinted with the permission of Paul R. DeMuro, Latham & Watkins LLP, San Francisco and Los Angeles, CA, paul.demuro@lw.com

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Most suppliers of durable medical equipment, prosthetics, orthotics and supplies (DMEPOS) were required to have met new quality standards by October 1, 2009, and obtain a surety bond by October 2, 2009, as required by the Medicare Prescription Drug, Improvement and Modernization Act of 2003 (MMA) and the Balanced Budget Act of 1997 (BBA). In order to obtain Medicare billing privileges, DMEPOS suppliers must become accredited by meeting Medicare's business and product-specific service and quality standards. The business standards include: (1) how the company is run, (2) how finances and staff performance are managed, (3) how well the company takes care of its consumers, (4) the safety of their products, and (5) whether the company’s information management systems are in place. The product-specific service standards include: (1) intake, (2) delivery and setup, (3) training and instruction of the beneficiary and their caregiver, and (4) follow-up service. According to CMS, the vast majority of Medicare DMEPOS suppliers have met the deadlines to apply and become accredited. CMS is continuing to work to complete the evaluations of those suppliers whose accreditation applications are still under review, which could take as long as 60 days. Suppliers wishing to participate in the Medicare DMEPOS competitive bidding program must be fully accredited to submit a bid. CMS-deemed accreditation organizations have been required by the MMA to use these new quality standards to evaluate the applications of thousands of DMEPOS suppliers during the past three years. More than 50,000 DMEPOS suppliers (70 percent) have already been accredited. The accreditation requirement applies to suppliers of durable medical equipment, medical supplies, home dialysis supplies and equipment, therapeutic shoes, parenteral/enteral nutrition, transfusion medicine and prosthetic devices, prosthetics and orthotics unless a professional exemption applies. Pharmacies, pedorthists, mastectomy fitters, orthopedic fitters/technicians and athletic trainers must also comply. Congress is considering extending the deadline for pharmacies to meet this accreditation requirement to January 1, 2010, with the exception of those pharmacies that plan to bid in the DMEPOS competitive bidding program. The BBA surety bond requirement requires certain DMEPOS suppliers to obtain and maintain a $50,000 surety bond. The surety bond limits the risk to the Medicare program from fraudulent equipment suppliers and helps to ensure that Medicare beneficiaries receive medical items that are “reasonable and necessary” from legitimate suppliers. CMS Fact Sheet, Oct. 1, 2009

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Individuals’ genetic information will have greater protections through an interim final rule recently issued by CMS, the Employee Benefits Security Administration, the Internal Revenue Service and proposed regulations issued by the Office of Civil Rights (OCR) implementing the Genetic Information Nondiscrimination Act of 2008 (GINA) (PubLNo 110-233). GINA provisions. GINA protects individuals against discrimination based on their genetic information in health coverage (Title I) and employment (Title II). GINA established three rules that generally prohibit a group health plan and a health insurance issuer in the group market from: (1) increasing the group premium or contribution amounts based on genetic information; (2) requesting or requiring an individual or family member to undergo a genetic test; and (3) requesting, requiring, or purchasing genetic information prior to or in connection with enrollment, or at any time for underwriting purposes. Interim final rule. Under the interim final rule, group health plans, health insurance issuers in the group and individual markets, and issuers of Medicare supplemental policies cannot: increase premiums for the group based on the results of one enrollee’s genetic information, deny enrollment, impose pre-existing condition exclusions, or do other forms of underwriting based on genetic information. The interim regulations also prohibit group health plans and health insurance issuers in the group and individual markets from requesting, requiring, or buying genetic information for underwriting purposes or in connection with enrollment; and asking individuals or family members to undergo a genetic test. OCR's proposed rule. OCR's proposed rule would implement Section 105 of Title I of GINA regarding the privacy and confidentiality of genetic information and amend the HIPAA Privacy Rule to prohibit health plans from using or disclosing genetic information for underwriting purposes. The proposed rule modifies the Privacy Rule to (1) explicitly provide that genetic information is health information for purposes of the Privacy Rule, (2) prohibit health plans from using or disclosing protected health information for underwriting purposes, (3) revise the provisions related to the Notice of Privacy Practices for health plans that perform underwriting, (4) make a number of conforming modifications to definitions and other provisions of the Rule, and (5) make technical corrections to update the definition of health plan. HHS Press Release, Oct. 1, 2009; Interim final rule, 74 FR 51664, Oct. 7, 2009; Proposed rule, 74 FR 51698, Oct. 7, 2009; Health Care Compliance Reporter ¶700,234 and ¶730,075, respectively.

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