Former employee-turned Whistleblower Craig Thomas will collect $2.7 million out of the $14.5 million settlement that Sound Inpatient Physicians Inc. (SIP) will pay $14.5 million to settle allegations that it overbilled Medicare and other federal health care programs under a settlement announced by the Justice Department on July 3, 2013. The SIP announcement comes the same day the Justice Department announced medical device manufacturer TranS1 Inc., now known as Baxano Surgical Inc., will pay $6 million to resolve whistleblower-prompted FCA allegations that TranS1 Inc. caused health care providers to submit false claims to Medicare and other federal health care programs for minimally-invasive spine surgeries.
Both the SIP and TranS1 Inc. charges and settlement clearly show the ever-growing risk of Justice Department prosecution that providers face when billing Medicare or other government programs for care beyond the level delivered and documented in the medical record. The litigation and resulting settlement also show the too-often underappreciated rule that employees, vendors and other whistleblowing insiders increasingly play in the initiation and success of these prosecutions and how they impact the ability of providers charged with fraud to prove they have billed Medicare or other federal health plans accurately and honestly for services actually delivered in the manner documented in the record and in accordance with applicable Federal program rules.
To mitigate these exposures, health care providers both should strengthen their health care medical record documentation, billing and other fraud and compliance programs and their employee, vendor and other workforce relations and management processes.
Former SIP Employee’s Qui Tam Claim Prompted Suit
The settlement resolves charges that SIP fraudulently inflated billings to government programs brought in U.S. ex rel. Craig Thomas v. Sound Inpatient Physicians, Inc. and Robert A. Bessler, Civil Action No. C09-5301RBL (W.D. Wash.) that initially came to the government’s attention through a lawsuit filed by former SIP employee, Craig Thomas, under the qui tam, or whistleblower, provisions of the False Claims Act (FCA). The FCA allows private citizens to bring civil actions on behalf of the government and share in any recovery. Thomas will receive $2.7 million of the $14.5 million settlement for exposing Sound Physicians’ inflated claims.
In the lawsuit, the Justice Department alleged that SIP, a Tacoma, Washington-based employer of more than 700 hospitalists and post-acute physicians at 70 hospitals and a growing network of post-acute facilities in 22 states, between 2004 and 2012, knowingly submitted inflated claims to federal health benefits programs for its hospitalist employees for higher and more expensive levels of service than documented by hospitalists in patient medical records.
The SIP civil settlement illustrates the growing reliance on whistleblowers and other FCA tools by the Federal government in its rising campaign against false claims and other health care fraud by physicians, hospitals and other health care providers under the Health Care Fraud Prevention and Enforcement Action Team (HEAT) initiative announced in May 2009 by Attorney General Eric Holder and Health and Human Services (HHS) Secretary Kathleen Sebelius. Since January 2009, the Justice Department claims to have recovered a total of more than $14.7 billion through FCA cases, with more than $10.7 billion of that amount recovered in cases involving fraud against federal health care programs.
TranS1 Inc. Whistleblower Gets $1M+ Out of $6M Settlement
Whistleblower claims also prompted the charges and settlement announced against medical device manufacturer TranS1 Inc. The Justice Department announced July 3 that TranS1 Inc. has agreed to pay the United States $6 million to resolve allegations under the FCA. Whistleblower Kevin Ryan, whose qui tam claim prompted the investigation that lead to the settlement will collect $1,020,000 from the settlement.
The settlement resolves Justice Department charges developed out of the qui tam action of a former employee that TranS1 knowingly caused health care providers to submit claims with incorrect diagnosis or procedure codes for minimally-invasive spine fusion surgeries using Trans1’s AxiaLIF System. That device was developed as alternative to invasive spine fusion surgeries. The United States alleges that TranS1 improperly counseled physicians and hospitals to bill for the AxiaLIF System by using incorrect and inaccurate codes intended for more invasive spine fusion surgeries. The Justice Department alleged that, as a result, health care providers received greater reimbursement than they were entitled to for performing the minimally-invasive AxiaLIF procedures.
The Justice Department also claimed TranS1 knowingly paid illegal remuneration to certain physicians for participating in speaker programs and consultant meetings intended to induce them to use TranS1 products, in violation of the Federal Anti-Kickback Statute, 42 U.S.C. § 1320a-7b(b), and thereby caused false claims to be submitted to federal health care programs. The Anti-Kickback Statute prohibits offering or paying remuneration to induce referrals of items or services covered by federally-funded programs and is intended to ensure that a physician’s medical judgments are not compromised by improper financial incentives and are based solely on the best interests of the patient.
In addition, the Justice Department alleged that TranS1 promoted the sale and use of its AxiaLIF System for uses that were not approved or cleared by the U.S. Food and Drug Administration, including use in certain procedures to treat complex spine deformity, and which were thus not covered by federal health care programs.
“A medical device manufacturer violates the law when it advises physicians and hospitals to report the wrong codes to federal health insurance programs in order to increase reimbursement rates,” said Rod J. Rosenstein, U.S. Attorney for the District of Maryland. “Health care providers are required to bill federal health care programs truthfully for the work they perform.”
As part of the settlement, TranS1 has agreed to enter into a corporate integrity agreement with the Office of Inspector General of the Department of Health and Human Services. That agreement provides for procedures and reviews to be put in place to avoid and promptly detect conduct similar to that which gave rise to this matter.
Mitigate Risks With Effective Oversight of Both Documentation & Operations
As Acting Assistant Attorney General for the Civil Division Stuart F. Delery noted in the settlement announcement. “Physicians who participate in Medicare and other federal health care programs must document and bill for their services accurately and honestly.” With qui tam and other whistleblower participation, the Justice Department, HHS and other federal and state fraud investigators go beyond merely challenging whether the medical record documentation supports the charges billed to question whether the medical record itself accurately reflects the care in fact delivered by relying upon testimony of employees or other “insiders” often with an axe to grind against the provider.
To mitigate these exposures, health care providers clearly should work diligently both to ensure that their billing and other compliance programs accurately, honestly and completely document the care provided and code and bill for those services in accordance with the currently applicable federal program rules. While these compliance and risk management programs are indispensable components of any effective health care fraud compliance program, health care providers also should recognize that the effectiveness of their health care fraud and other compliance program also may depend on the effectiveness of their operational and workforce oversight and management. Along with effective billing and other fraud detection and compliance programs, providers also need effective medical quality and records documentation, provider and workforce performance and management, investigations and other management programs.
As a key element of these activities, providers should constantly be on watch for evidence of gaps between the medical and billing documentation and the factual realities looking at broad range of sources. Providers should target these activities to cover both specific medical documentation, coding and care, and other operational indicators that could show a problem. With qui tam and other whistleblower claims rising, however, providers should keep in mind that mere auditing of records and billing patterns alone often fails to uncover key evidence of potential concerns.
To help identify potential areas of scrutiny, providers should carefully monitor and examine the adequacy of their compliance and risk management agreements against corporate integrity agreements with other providers who have reached settlements with the Department of Justice, HHS Office of Inspector General or other agencies like the TranS1 Inc. Corporate Integrity Agreement .
Health care providers also should take into account a plethora of other potential indicators including but not limited to peer review and quality assurance data, deficient as well as inexplicably exceptional medical record or other record keeping documentation, hotline, exist interview and other workforce feedback, disagreements among providers in patterns of care, political and interpersonal differences, and a host of other indicators that could show a valid compliance concern or a developing hostility that could become the incentive for a whistleblower or other complaint. Providers should document these and other efforts to investigate, monitor and redress potential concerns In addition, providers also should guard against qui tam, retaliation and other claims by ensuring that their human resources, peer review, credentialing, background and other investigations, privacy and other operational activities are designed, documented to be both legally compliant and defensible.
For More Information Or Assistance
If you need assistance reviewing or responding to these or other health care related risk management, compliance, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer, may be able to help. Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 25 years experience advising health industry clients about these and other matters.
Ms. Stamer has extensive experience advising and assisting health care providers and other health industry clients to establish and administer compliance and risk management policies and to respond to DEA and other health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns. A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns including a number of programs and publications on OCR Civil Rights rules and enforcement actions. Her insights on these and other related matters appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, World At Work, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications. You can get more information about her health industry experience here. If you need assistance with these or other compliance concerns, wish to ask about arranging for compliance audit or training, or need legal representation on other matters please contact Ms. Stamer at (469) 767-8872 or via e-mail here.
If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile here. For important information about this communication click here.
About Solutions Law Press
Solutions Law Press™ provides business risk management, legal compliance, management effectiveness and other resources, training and education on human resources, employee benefits, compensation, data security and privacy, health care, insurance, and other key compliance, risk management, internal controls and other key operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press resources including:
- HHS Continues Preparations For Health Care Marketplace By Awarding $32M Of Grants To Up CHIP & Medicaid Enrollment
- Hospital Pay $275K To Settle HIPAA Charges After Sharing PHI With Press, Workforce In Response To Fraud Reports
- OCR Makes Technical Corrections To HIPAA Omnibus Final Rule
- Feds Arrest 36 More California & Florida Providers On Defrauding Medicare Of More than $66 Million
- HHS Proposes Increasing Health Care Fraud Reporting Rewards To Up To $9.9 Million
- CMS Proposes Changes To Acute Care Hospital & Skilled Nursing Facility Prospective Payment Rules
- OCR Shares New Tools to Educate Consumers and Providers about HIPAA Privacy and Security
- Bad Economy, Not Health Care Reform Accounts For Slowing Health Care Cost Trend
- Amgen Settlement Highlights Anti-Kickback Exposures From Whistleblowers, Need For Effective Compliance & Risk Management
- HHS Publishes Medicaid Expansion Final Regs, Invites Public Comment
- Hospitals with 2012 CMS Adverse Complaint Inspection Reports in AHCJ Data Bank Should Prepare Response
- CMS 2nd Recalculation Medicare Readmission Penalties In 6 Months Cuts Overall Penalties By $10M
- Hospital’s Disability Discrimination Settlement 4th In 5 Weeks For Justice Department
- Corpus Christi Radiology Group & Clinic $2.3 Million To Settle Health Care Fraud Charges
- Houston Ambulance Service Owner Convicted Of Health Care Fraud Faces Up To 70 Years
- Genesis Healthcare Disability HHS OCR Discrimination Settlement Reminder To Use Interpreters, Other Needed Accommodations For Disabled
- OSHA Safety Violations At Veterans’ Medical Center Reminder To Manage OSHA Compliance
- Federal Health Care Fraud & Abuse Recovery of $4.2 Billion In FY 2012 Shows Enforcement Risks Growing
- OCR, FTC Enforcement & Guidance Signals Need To Tighten Mobile Device & Application Security
- Unfair Labor Practice Settlements Reminds Hospitals To Handle Union Activities Carefully
- New Children’s Electronic Health Record Format Shared
- Justice Department Disability Discrimination With Pain Clinic Shows Provider ADA Exposures
- 7 Arrested, Charged In Detroit-Area Home Health Care Fraud Takedown
- OCR’s Long-Anticipated Omnibus HIPAA Privacy, Security, Breach Notification & Enforcement Rule Tightens Privacy Requirements, Require Action
- OCR Gives Providers Guidance On HIPAA Safety Disclosures
- Justice Department Settles FACE Act Lawsuit Against Abortion Protester
- ONC-Authorized Certification Bodies & Accredited Testing Labs Scope Expansion for 2014 Edition Testing & Certification
- OCR Pops Idaho Hospice In 1st HIPAA Breach Settlement Affecting < 500 Patients
- Medical Device Excise Tax Rules Supplemented
- Updated 2013 ACA Prescription Drug Fee Calculation & Payment Rules Released; 12/18 Deadline To File Form 8947
- Hospitals Urged To Tighten Inpatient & Outpatient Admission Records As OIG Audits Hospitals for New vs. Established Patients,
- OIG Recommends CMS, ONC Tighten EMR Incentive Program Rules To Improve Oversight
If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile here. For important information about this communication click here.
THE FOLLOWING DISCLAIMER IS INCLUDED TO COMPLY WITH AND IN RESPONSE TO U.S. TREASURY DEPARTMENT CIRCULAR 230 REGULATIONS. ANY STATEMENTS CONTAINED HEREIN ARE NOT INTENDED OR WRITTEN BY THE WRITER TO BE USED, AND NOTHING CONTAINED HEREIN CAN BE USED BY YOU OR ANY OTHER PERSON, FOR THE PURPOSE OF (1) AVOIDING PENALTIES THAT MAY BE IMPOSED UNDER FEDERAL TAX LAW, OR (2) PROMOTING, MARKETING OR RECOMMENDING TO ANOTHER PARTY ANY TAX-RELATED TRANSACTION OR MATTER ADDRESSED HEREIN. ©2013 Cynthia Marcotte Stamer, P.C. Non-exclusive license to republish granted to Solutions Law Press, Inc.. All other rights reserved.
slphealthcareupdate.com 