Compliance TODAY February 2013 a publication of the health care compliance association www.hcca-info.org Meet Lew Morris Senior Counsel with Adelman, Sheff and Smith in Annapolis, Maryland; former Chief Counsel to the Inspector General, Department of Health and Human Services See page 18 25 35 39 43 OIG 2013 Work Plan sheds light on new compliance projects: Part 2 New Medicare provider enrollment regulations: What compliance officers need to know Compliance challenges: Lessons from Oregon’s Coordinated Care Organizations New developments in the Department of Justice’s national ICD investigation Nathaniel Lacktman Idalie Cabrera and Al Monte Aurae Beidler Bradley M. Smyer This article, published in Compliance Today, appears here with permission from the Health Care Compliance Association. Call HCCA at 888-580-8373 with reprint requests. Feature by Bradley M. Smyer New developments in the Department of Justice’s national ICD investigation »» The DOJ is investigating implantable cardioverter defibrillator (ICD) claims under the False Claims Act. »» The DOJ released a “resolution model” for assessing and settling disputed cases. »» Total damages are assessed based on the type of claim and a facility-specific multiplier. »» Hospitals should use this investigation as an opportunity to demonstrate their compliance strengths. »» A number of important, unanswered questions still remain about the investigation. Dallas office of DLA Piper LLP. T Smyer he Department of Justice (DOJ) recently released a “resolution model” for hospitals involved in its national investigation of implantable cardioverter defibrillator (ICD) procedures performed outside of Medicare’s coverage policy. The DOJ has been investigating hospitals’ Medicare claims involving ICD implantation since at least 2010. The DOJ has notified hundreds of hospitals that it is investigating their ICD claims under the False Claims Act (FCA) based on standards established in CMS’s National Coverage Determination (NCD) 20.4. The DOJ’s resolution model presents medical review and documentation guidelines and a framework within which the DOJ proposes to settle claims subject to its investigation. Although the DOJ’s much anticipated resolution model provides some answers for hospitals that have received investigative demands, notices, or other requests from the DOJ, it also raises (or at least leaves unanswered) a number of important questions. Hospitals that are subject to the investigation must consider the immediate practical issues presented by the DOJ’s resolution model and develop a reasonable approach to the DOJ’s suggested settlement framework. All providers should carefully consider the long-term and far-reaching implications of the DOJ’s current approach and strengthen their own policies and processes. A quick look at the DOJ’s ICD resolution model The DOJ’s resolution model classifies ICD cases into six “categories” and proposes medical record documentation requirements and potential damages for each category. Category I involves claims for which reimbursement is allowed under indications Number 1 or Number 2 of NCD 20.4, or claims that involved a clinical trial or for which no Medicare payment was made. Category II represents potential non-compliance with the NCD that the DOJ will not enforce as part of its investigation. Cases in Category II include a number of “technical” or “timing” violations, including ICDs implanted between 30 and 40 days after an acute MI or between 67 and 90 days 888-580-8373 www.hcca-info.org Compliance Today February 2013 Bradley M. Smyer ([email protected]) is an Associate in the 43 Feature after a revascularization. NCD 20.4 contains stricter standards. Category II is notable because it represents cases for which the DOJ will not seek enforcement, even if those cases are not otherwise consistent with the government’s interpretation of NCD 20.4. Categories III through VI represent claims for which the DOJ will seek damages (see table 1). charges. The DOJ has suggested that it will be necessary to assign the correct diagnosisrelated group (DRG) code in order to calculate this difference. Outlier payments may also need to be recalculated. The DOJ will then endeavor to increase these single damages calculations by a multiplier to arrive at a total damages amount for Table 1: Categories under the DOJ’s Resolution Model DAMAGES Compliance Today February 2013 Category Description of cases within category I. Covered by the NCD and/or excluded from this investigation: Covered under NCD 20.4 Indication #1 Covered under NCD 20.4 Indication #2 Covered under a Clinical Trial No Medicare payment II. DOJ No Enforcement Categories (Buckets): No MI (Proper code or no payment change) Pacemaker CRT-D Replacement Technical violation (Late-stage implants) Syncope Bridge to Transplant NCD 20.4 Indication #3 (Familial/Inherited conditions) III. Single Damages x Multiplier NA NA NA NA NA NA NA NA None None None None None None None None None None None None None None None None DOJ Category — With Enforcement: Previously Qualified Yes Yes IV. Coding Error (without repeating patterns): No MI (Coding error with payment difference) No ICD (Coding error) No CABG/PTCA (Coding error) Yes Yes Yes Yes Yes Yes V. Not Covered By NCD or DOJ Categories Yes Yes VI. Not Medically Indicated Yes Yes Single damages and multipliers The resolution model suggests higher total damage amounts for cases in the higher categories. The single damages amount under each category is the difference between what the facility was paid on each claim and what the facility should have been paid on each claim without the ICD code(s) and related 44 www.hcca-info.org 888-580-8373 each category. The multiplier will presumably be greater at each successive category, but the DOJ may consider many factors in proposing multipliers, including (but not limited to) patient harm, patterns, compliance efforts and effectiveness, ICD registry submissions, and knowledge evidence. The multipliers will be determined through discussions with each facility. Feature For hospitals that have received demands or notices from the DOJ, the resolution model presents some practical challenges. The DOJ’s resolution model contemplates that hospitals will have the burden of reviewing, analyzing, and classifying inpatient ICD claims. Such a review can be costly. Practically speaking, however, hospitals should view the resolution model as an opportunity to obtain a favorable result through effective advocacy. For example, the government’s proposed multipliers at each level will be developed for each facility based on a number of factors, including compliance efforts and effectiveness. It is important to engage in an active dialogue with the DOJ about your efforts and positions, and seek legal counsel when appropriate. Practical tips for hospitals: ·· Engage in active dialogue with the DOJ ·· Highlight your strengths ·· Reassess your compliance program ·· Seek a comprehensive release of liability Even for hospitals that are not currently under ICD investigation, the DOJ’s investigation and resolution model present an opportunity to assess vulnerabilities and improve processes. Hospitals that are not currently under investigation may review claims and consider the need for voluntary refunds or other preventative and remedial measures. Hospitals can also develop ICD policies, procedures, and documentation guidelines and educate all physicians who perform cardio implants. Contact us email helpteam @ hcca-info.org phone888-580-8373 fax952-988-0146 mailHCCA 6500 Barrie Road, Suite 250 Minneapolis, MN 55435 Hospitals can also develop system-wide monitoring, dissemination, and education policies based on NCDs and applicable Local Coverage Determinations. Unanswered questions Although the DOJ’s resolution model presents a framework within which the DOJ proposes to settle claims subject to its ICD investigation, it still leaves unanswered a number of fundamental questions about the legal basis for the investigation and the practical realities of any proposed settlement. For example, will DOJ settlements trigger the HHS-OIG to ask for Corporate Integrity Agreements? How does the DOJ justify using a resolution model that includes some claims that may be barred by the statute of limitations? If a hospital lacks the scienter for violation of the FCA (which appears likely, based on vague NCD standards), how does the DOJ justify the use of multipliers in the resolution model? A few years into the DOJ’s investigation, hospitals still have limited information about the basis of the investigation and what settlements under the resolution model may look like. In addressing these concerns, hospitals should seek the advice of qualified counsel and consultants to address the best resolution and approach, to deal with the many nuances and complexities involved in this matter, and to contend with the high risks involved in FCA investigations. All providers, however, can take immediate steps to enhance their ICD policies and procedures. To learn how to place an advertisment in Compliance Today, contact Margaret Dragon: email phone margaret.dragon @ hcca-info.org 781-593-4924 Compliance TODAY February 2013 A PUBLICATION OF THE HEALTH CARE COMPLIANCE ASSOCIATION WWW.HCCA-INFO.ORG Meet Lew Morris Senior Counsel with Adelman, Sheff and Smith in Annapolis, Maryland; former Chief Counsel to the Inspector General, Department of Health and Human Services See page 18 25 35 39 43 OIG 2013 Work Plan sheds light on new compliance projects: Part 2 New Medicare provider enrollment regulations: What compliance officers need to know Compliance challenges: Lessons from Oregon’s Coordinated Care Organizations New developments in the Department of Justice’s national ICD investigation Nathaniel Lacktman Idalie Cabrera and Al Monte Aurae Beidler Bradley M. Smyer 888-580-8373 www.hcca-info.org Compliance Today February 2013 What this means for providers today and tomorrow 45
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