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Meet Greg Jones ...continued from page 15 several conferences. Despite the fast pace, which is stressful at times, it has been a very positive and fulfilling experience. RS: Having previously worked in the HHS Office of Inspector General, how was the transition to CMS GJ: Coming to CMS has given me the opportunity to learn about the policy and operational side of Medicare and see what it takes to run the day-to-day operations of what is essentially the largest insurance program in the world. In that regard it is definitely a different perspective. At the same time, however, it has been great to work collaboratively with my former colleagues to prepare for the implementation of the drug benefit. My experience at the OIG has been invaluable in having an “eye” for identifying potential vulnerabilities in the drug benefit and it also helps me understand the needs of the OIG and our other law enforcement partners such as the Department of Justice. RS: Tell us the status of the Fraud, Waste, and Abuse summary that was published in June 2005. GJ: As most of your members know, we released for public comment an eight page Fraud, Waste, and Abuse Summary document in June 2005. Since then we have spent time reviewing the public comments and working with policy experts within the agency, as well as the law enforcement community, to develop a much more comprehensive document. We expect to release for public comment the more detailed document in January 2006, and hope to finalize it by early Spring 2006. RS: You have a lot on your plate these days with Medicare Part D implementation. I know this is a big question and we probably don’t have enough room for a complete answer, but if you had to put together a list, what are the main issues health care compliance officers need to know about Medicare Part D (fraud and abuse, training, policies and procedures) GJ: Well, three things come to mind: ■ The role of the plans themselves in overseeing their downstream subcontractors involved in the delivery of the drug benefit ■ The role and responsibilities of the Compliance Officer at each plan ■ The need to develop an audit workplan to monitor for efficient and accurate delivery of the Part D benefit I encourage all your members to pay special attention to these sections in the Fraud, Waste, and Abuse Guidance document and provide feedback to us during the public commenting period. RS: Would you share with us some of the Medicare Part D challenges GJ: One area we are paying particular attention to at this time is marketing. All Part D Plans are required to ensure that marketing activities—whether they initiate from paid marketing employees or independent agents—comply with the Marketing Guidelines. To date, CMS has received complaints alleging that agents have: ■ Offered beneficiaries a cash payment as an inducement to enroll in Part D ■ Conducted unsolicited door-to-door sales ■ Stated that the agent works for or is contracted with the Social Security Administration or CMS ■ Misrepresented the product being marketed as an approved Part D Plan when it actually is a Medigap policy or non-Medicare drug plan ■ Misrepresented the Prescription Drug Plan being marketed ■ Requested beneficiary information or check numbers, which may be a prelude to identity theft ■ Asking beneficiaries to pay “up front” premiums Organizations found to violate CMS’s Marketing Guidelines will be placed under a corrective action plan (CAP). If the organization fails to correct the deficiency under the CAP, then intermediate sanctions such as a freezing of marketing and enrollment may be imposed. If after the imposition of intermediate sanctions the problem has not been corrected, a Civil Money Penalty may be imposed or the organization’s contract may be terminated. Cases appearing to be potentially fraudulent will be referred to the OIG. Protecting beneficiaries from aggressive marketing tactics is something we take very serious and plan to monitor closely. RS: Tell us about the Medicare Drug Integrity Contractors (MEDICs). GJ: The MEDICs are companies CMS is contracting with to assist us in combating fraud, waste, and abuse in the Medicare Part D prescription drug benefit. RS: What are some of the activities a MEDIC may perform GJ: The MEDICs will: ■ Analyze data to identify problems that indicate fraud or abuse may be occurring ■ Conduct complaint investigations ■ Develop and refer cases to the appropriate law enforcement agency as needed; and ■ Support ongoing law enforcement investigations. Our Enrollment and Eligibility MEDIC, “Health Integrity, LLC” is operational and their primary focus is to investigate Part D complaints, which at this time are mostly issues related to enrollment, eligibility determination, and marketing. RS: Will the Medicare Part D Manual include information about fraud January 2006 16 Health Care Compliance Association • 888-580-8373 • www.hcca-info.org
GJ: Yes. The Fraud, Waste, and Abuse Guidance document is scheduled to be a chapter in the Part D Plan Manual. RS: What has the CMS Program Integrity Group been doing to prepare for the implementation of the drug benefit GJ: I see our strategy as a three-prong approach that includes: 1. Contracting with the MEDICs 2. Reviewing and providing comments on CMS’s Part D regulation, policies, and subregulatory guidance and developing our own Fraud, Waste and Abuse Guidance document. 3. Coordinating with our partners in the law enforcement community such as the OIG, DOJ, FBI, States, and many other government agencies, as well as private organizations such as HCCA, to collaborate on approaches to address and combat fraud, waste, and abuse in the Part D prescription drug benefit. 4. Lastly, we have spent a lot of time speaking with experts, which includes some recent hires at CMS with direct industry experience, to educate ourselves about the pharmaceutical drug industry. This has been invaluable and I believe puts us in a much better position to ensure the integrity of the Part D prescription drug benefit and the Medicare Trust Fund. For general Medicare information, including the Prescription Drug Benefit, please contact 1-800-MEDICARE or visit our website at www.medicare.gov. To report any suspected Fraud, Waste, and Abuse in the Medicare Part D Prescription Drug program, please contact 1-877-7SAFERX or e-mail EDICinfo@healthintegrity.org ■ By Michelle Wilcox DeBarge and Amanda Littell Editor’s note: Michelle Wilcox DeBarge, JD, is a Partner and Amanda Littell, JD, MPH, an Associate in the law firm of Wiggin and Dana. Michelle Wilcox DeBarge may be reached by telephone at 860/297-3702 or by e-mail at mdebarge @wiggin.com, and Amanda Littell may be reached by telephone at 203/498- 4529 or by e-mail at alittell@wiggin.com. On November 28, 2005, the Office of the Inspector General (OIG) for the U.S. Department of Health and Human Services issued draft compliance guidance (Guidance) for recipients of extramural research awards from the National Institutes of Health (NIH) and other agencies of the U.S. Public Health Service (PHS) See 70 Fed. Reg. 71,312. The Guidance highlights the following three risk areas for recipients of PHS awards: 1. Time and effort reporting 2. Properly allocating charges to award projects 3. Reporting of financial support from other sources The Guidance also adds an eighth element to the OIG’s standard seven elements for an effective compliance program: defining roles and responsibilities and assigning oversight responsibility. Scope of guidance With the goal of preventing the submission of erroneous claims and combating fraud and abuse in federal health care programs, the OIG in the last several years has developed a series of compliance program guidance aimed at various segments of the health care industry. This guidance encourages development of an internal compliance infrastructure and organizational control to help monitor and ensure compliance with applicable laws. The guidance also lists specific risk areas applicable and of potential concern to the respective industry segments. An organization’s establishment of a compliance program in line with the compliance program guidance is voluntary, but highly recommended by the OIG. Although there has been a notable increase in governmental enforcement actions and whistleblower cases related to grant compliance and administration, the publication of the Guidance is the first official word from the OIG on the issue of research compliance program elements. The OIG had published a notice on September 5, 2003 soliciting information and recommendations for developing compliance program guidance for recipients of NIH research grants. Based on comments to that notice, the OIG published the Guidance for the purpose of offering a “checklist” of items that the OIG believes are critical for developing compliance programs or refining an existing compliance program. The OIG also expresses its view in the Guidance that all research institutions would benefit from compliance programs to foster a “culture of compliance” that begins at the Continued on page 18 Health Care Compliance Association • 888-580-8373 • www.hcca-info.org 17 January 2006
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