CRAIGroup

Compliance, Risk Assessment, and Investigations Group

About

Healthcare Qui Tam (“Whistleblower”) litigation has increased exponentially in the last 30 years, with over 6,000 Qui Tam cases resulting in over $27.5 Billion in settlements and judgments since 1987. Over the course of my career, I have found that a significant percentage of healthcare providers are unknowingly making themselves vulnerable to Qui Tam lawsuits because they are improperly and/or inaccurately coding claims that are submitted for processing and payment to Medicare Administrative Contractors (MACs) and state Medicaid agencies. I started CRAIGroup to help these providers get compliant and stay compliant with federal and state healthcare laws and regulations and mitigate their risk of potential Qui Tam lawsuits. — Craig Ratner, Founder and President

Craig Ratner, JD, CHC, CPC
Founder and President

Craig Ratner is one of the few attorneys in America who is both Certified in Healthcare Compliance (CHC) by the Compliance Certification Board of the Health Care Compliance Association and a Certified Professional Coder (CPC) with AAPC.

In October 2016, Craig founded CRAIGroup (formerly Qui Tam Prevention Group), a firm committed to helping healthcare providers stay compliant with federal and state laws and regulations. Prior to starting CRAIGroup, Craig was Compliance Officer at Abington Jefferson Health, where he developed, implemented, and maintained the hospital system’s compliance program. Before working at Abington Jefferson Health, Craig was Assistant General Counsel, Strategic Initiatives at DaVita and provided primary legal and compliance support to DaVita Rx, the company’s full-service pharmacy subsidiary, and VillageHealth DM, LLC, the company’s renal integrated care management organization. Prior to his tenure at DaVita, Craig spent eight years as in-house counsel for two companies that specialize in government-sponsored health plans – AmeriHealth Caritas and Centene Corporation.

Craig has a B.A. in Political Science from George Washington University, a J.D. from Temple Law School, and an M.P.A. from the Fels Institute of Government at the University of Pennsylvania.

Services

Outsourced Compliance Officer (OCO)

Compliance Program Support

An effective compliance program can be the first line of defense against governmental inquires, audits, and investigations. One of the Affordable Care Act’s “Seven Core Elements of an Effective Compliance Program” is designating a Compliance Officer. Rather than appointing an individual within your organization to serve as Compliance Officer, you can outsource this function to the compliance experts at CRAIGroup. As your OCO, CRAIGroup will ensure that your practice fulfills the “Seven Core Elements,” including written policies and procedures, formal compliance education and training for you and your employees, and ongoing auditing and monitoring of systems to assess the effectiveness of your compliance program.

Risk Assessment and Mitigation

CRAIGroup will evaluate the accuracy of the Medicare claims you have submitted to the Centers for Medicare and Medicaid Services (CMS) and assess your coding proficiency (CPT, ICD-10-CM, and HCPCS). We will also review the results of Medicare Recovery Audit Contractor (RAC), Medicaid Integrity Program (MIP), and state Medicaid agency audits from the past three years. CRAIGroup will then prepare a Risk Assessment Profile, including a detailed analysis of Medicare claims data, identification of potential coding inaccuracies and compliance violations, and the risk of unintended federal and state False Claims Act (FCA) violations. Finally, we will prepare a Risk Mitigation Plan to correct past inaccuracies and ensure future long-term compliance with all recognized medical coding and billing guidelines.

Compliance Investigations

CRAIGroup works with outside legal counsel to conduct targeted compliance investigations of medical practices. Since our Founder and President, Craig Ratner, is an attorney, we can conduct privileged investigations and assert the attorney-client privilege and the work product immunity protection. Moreover, CRAIGroup is better suited to analyze legal issues, examine legal consequences, and render objective legal advice regarding potential defenses, liabilities, and corrective actions.

Work

Compliance Program Materials

Code of Conduct

Compliance Investigations

Compliance Investigation Memo #1

Compliance Investigation Memo #2

Compliance Investigation Interview Notes

Compliance Research Memo #1

Frequently Asked Questions

What are the Seven Core Elements of an Effective Compliance Program?

1. Implement written compliance policies, procedures, and standards of conduct;

2. Designate a compliance officer and compliance committee, who will be responsible for monitoring compliance efforts and enforcing practice standards;

3. Conduct effective training and education on the compliance policies, procedures, and standards of conduct;

4. Develop effective lines of communication to facilitate communication with staff and allow anonymous reporting mechanisms;

5. Conduct internal monitoring and auditing by performing periodic self-audits;

6. Enforce standards for employees through well-publicized disciplinary guidelines; and

7. Respond promptly to detected offenses and develop corrective action plans.

Why does my medical practice need a Compliance Program?

While the Centers for Medicare & Medicaid Services (“CMS”) and the OIG have recommended voluntary compliance programs since 2000 to help avoid erroneous claims and fraud, the Patient Protection and Affordable Care Act (“PPACA”) takes compliance a step further and mandates compliance programs. Section 6401 of PPACA provides that a “provider of medical or other items or services or supplier within a particular industry sector or category” shall establish a compliance program as a condition of enrollment in Medicare, Medicaid, or the Children’s Health Insurance Program (“CHIP”). This new requirement significantly expands compliance risks for most healthcare providers.

Why does my medical practice need a Compliance Officer and why should I outsource this function?

The third (of seven) core elements of an effective compliance program is the designation of a compliance officer or contact(s) to monitor compliance efforts and enforce practice standards.

In the HHS OIG Compliance Program Guidance for Individual and Small Group Physician Practices (published in the Federal Register on October 5, 2000), it reads that “[i]n situations where staffing limitations mandate that the practice cannot afford to designate a person(s) to oversee compliance activities, the practice could outsource all or part of the functions of a compliance officer to a third party, such as a consultant…However, if this role is outsourced, it is beneficial for the compliance officer to have sufficient interaction with the physician practice to be able to effectively understand the inner workings of the practice.”

What is the federal False Claims Act?

The False Claims Act (‘ FCA”), 31 U.S.C. § 3729 et seq., provides for liability for triple damages and a penalty from $5,500 to $11,000 per claim for anyone who knowingly submits or causes the submission of a false or fraudulent claim to the United States government.

What is a QuiTam ("Whistleblower") lawsuit?

The FCA includes an ancient legal device called a “qui tam” provision (from a Latin phrase meaning “he who brings a case on behalf of our lord the King. as well as for himself”). This provision allows a private person. known as a “relator” – otherwise known as a “whistleblower – to bring a lawsuit on behalf of the United States. where the private person has information that the named defendant has knowingly submitted or caused the submission of false or fraudulent claims to the United States. The relator need not have been personally harmed by the defendant’s alleged conduct.

What does it mean when the government "intervenes" in a Qui Tam lawsuit?

The government investigates the allegations. often with the assistance of the whistleblower’s attorney. and decides whether it will join, or “intervene,” in the case. At the conclusion of the investigation. the Department of Justice must choose one of three options named in the False Claims Act: (1) intervene in one or more counts of the pending Qui Tam action. This intervention expresses the Government’s intention to participate as a plaintiff in prosecuting that count of the complaint; (2) decline to intervene in one or all counts of the pending qui tam action. If the United States declines to intervene. the relator and his or her attorney may prosecute the action on behalf of the United States. but the United States is not a party to the proceedings apart from its right to any recovery. This option is frequently used by relators and their attorney, (3) move to dismiss the relator’s complaint either because there is no case. or the case conflicts with significant statutory or policy interests of the United States.

What if I didn't know I may have submitted a false claim to Medicare or Medicaid?

While the FCA imposes liability only when the claimant acts “knowingly,” it does not require that the person submitting the claim have actua lknowledge that the claim is false. A person who acts in reckless disregard or in deliberate ignorance (i.e., buries his/her head in the sand) of the truth or falsity of the information can also be found liable under the FCA. Specifically, the FCA states that the terms “knowing” and “knowingly” mean that a person, with respect to information – (a) has actual knowledge of the information; (b) acts in deliberate ignorance of the truth or falsity of the information; or (c) acts in reckless disregard of the truth or falsity of the information.

What if I never intended to defraud Medicare or Medicaid?

If the government and/or the relators and their attorney can show that you acted in reckless disregard or in deliberate ignorance of the truth or falsity of the information, the FCA does not require them to show proof of your specific intent to defraud Medicare or Medicaid. In sum, the FCA imposes liability on any person who submits a claim to the federal government that he or she knows (or should know) is false.

Resources

HHS OIG Work Plan and Active Work Plan Items

HHS OIG Work Plan 2017 (Last annual Work Plan before moving to monthly update process)

Active Work Plan Item: Questionable Billing for Off-the-Shelf Orthotic Devices, January 2018

Active Work Plan Item: Data Briefs Regarding Financial Relationships Reported to the Open Payments Program, December 2017

Active Work Plan Item: Opioids in Medicaid: Concerns about Extreme Use and Questionable Prescribing in Selected States, November 2017

Active Work Plan Item: Home Health Compliance with Medicare Requirements, October 2017

Active Work Plan Item: Physical Therapists - High Use of Outpatient Physical Therapy Services, October 2017

Active Work Plan Item: Review of Medicare Payments for Bariatric Surgeries, October 2017

Active Work Plan Item: Sleep Disorder Clinics – High Use of Sleep-Testing Procedures, November 2016

HHS OIG Studies

OIG Study: Escalating Medicare Billing for Ventilators Raises Concerns, September 2016

OIG Study: Questionable Billing for Medicare Ophthalmology Services, September 2015

OIG Study: Improper Payments for Evaluation and Management Services Cost Medicare Billions in 2010, May 2014

OIG Study: Sleep Disorder Clinics – High Use of Sleep-Testing Procedures, October 2013

OIG Study: Inappropriate and Questionable Billing by Medicare Home Health Agencies, August 2012

HHS OIG Compliance 101 Materials

Compliance Tips 101 (Health Care Fraud Enforcement Action Team (HEAT), Office of Inspector General (OIG))

Corporate Integrity Agreements (CIA)

Corporate Integrity Agreement (CIA) Between HHS OIG and James P. Ralabate, M.D., and Primary Care Associates, P.C., January 24, 2013

Evolution of the Seven Core Elements of an Effective Compliance Program

Seven Elements of an Effective Compliance and Ethics Program (U.S. Federal Sentencing Guidelines, Sec. 8B2.1, pp. 9–14, effective November 1, 1991)

HHS OIG Compliance Program Guidance for Individual and Small Group Physician Practices (65 Fed. Reg. 59434; October 5, 2000)

Compliance Programs (Section 6401(a)(8) and (b)(5) of the Patient Protection and Affordable Care Act "Obamacare," June 9, 2010)

Compliance Plans for Providers and Suppliers; Final Rule (76 Fed. Reg. 5942, pp. 5941-5943, February 2, 2011)