The intense focus of government prosecutors and regulators on the health care industry in combatting fraud has become a permanent part of the legal landscape.  And since fraud “follows the money,” such focus is really an inevitable byproduct of the enormous financial resources spent by public and private payers on health care annually.

Given Mr. Kaiser’s extensive knowledge and experience in health care fraud matters as a former federal prosecutor in two of the nation’s premier prosecuting offices, as the former Chief of Health Care Fraud Prosecutions for the United States Attorney’s Office in the Eastern District of New York, and as a senior health care consulting professional, Kaiser Law Firm, PLLC is exceptionally well-situated to assist health care providers and businesses cope with this kind of government scrutiny.  Having previously directed health care fraud investigations performed under a range of criminal and civil health care fraud and abuse laws, Mr. Kaiser brings a unique insider’s perspective to these matters that he can leverage on behalf of his clients in attempting to achieve the best possible results.

Kaiser Law Firm, PLLC can assist in a variety of ways, including fraud and abuse counseling and monitoring, compliance program development, performing internal investigations, responding to government information requests, negotiating resolutions of government investigations, assisting in transaction-related regulatory due diligence and, of course, defending against civil and criminal fraud allegations.

Kaiser Law Firm, PLLC offers its services to all segments of the health care industry, including hospitals, health systems and academic medical centers, skilled nursing facilities, assisted living facilities, home health agencies, hospices, dialysis facilities, clinical laboratories, diagnostic testing facilities, ambulatory surgery centers, physicians/group practices, drug manufacturers and wholesalers, medical device manufacturers, suppliers and distributors, therapy companies, physician group practices and management companies.

Compliance Program Development and Counseling

Internal compliance programs are the first line of defense in preventing misconduct and, as a result of prosecution guidelines promulgated by the Department of Justice (“DOJ”) and key provisions of the United States Sentencing Guidelines impacting business organizations, an effective corporate compliance program can protect a health care company under investigation by reducing the likelihood of a criminal charge and shielding the company from suffering harsher penalties or stricter sentences.  In addition, such programs are now mandatory under the provisions of the Patient Protection and Affordable Care Act (“PPACA”), as well as under some state Medicaid programs.  A series of guidelines issued by the Department of Health and Human Services, Office of Inspector General (“HHS-OIG”) prescribe core elements to be included in the corporate compliance programs of various catgories of providers; these elements generally track the requirements for compliance programs contained in the Sentencing Guidelines.  In this brave new world of regulation, not having a compliance program is no longer a realistic option, and even providers who have installed such programs should have them reviewed, updated and monitored for effectiveness.

Kaiser Law Firm, PLLC is able to assist clients navigate this complex, ever-changing world of government regulation and enforcement. Our services include advice and representation relating to:

• Development of Compliance Programs and Codes of Conduct
• Ongoing Compliance Counseling and Program Monitoring and Assessment
• Compliance Training
• Internal Reviews and Audits
• Investigation Defense
• Corporate Integrity Agreements
• Voluntary Disclosures

Corporate Governance

Kaiser Law Firm, PLLC is well-equipped to provide advice to companies and their officers, boards of directors, board committees and individual directors in relation to creating and maintaining corporate compliance and governance programs, conducting internal investigations and responding to allegations of criminal and civil misconduct.

False Claims Act

Kaiser Law Firm, PLLC is capable of handling all phases of federal and state False Claims Act (“FCA”) litigation, including pre-litigation efforts aimed at the government’s intervention decision, motions practice to dismiss non-intervened whistleblower actions, and, where necessary, FCA discovery and trial work.  We will counsel clients regarding strategies for minimizing FCA risk and dealing with whistleblowers within their organizations.

Fraud and Abuse Counseling

Kaiser Law Firm, PLLC can advise on how best to interpret, and minimize the risks presented by, a wide variety of applicable federal and state fraud and abuse laws, including anti-kickback statutes, self-referral (Stark) laws, federal and state false claims statutes, HIPAA privacy requirements, and statutory provisions barring the marketing of misbranded medical devices and the “off-label” marketing of prescription medications.  We can perform risk assessments in connection with current business practices that may or may not be consistent with these legal requirements.  We can also assist clients in analyzing and navigating the thorny issues around a decision to self-disclose, and then take the lead with regulatory authorities in an effort to secure a favorable resolution.

Government Investigations

Kaiser Law Firm, PLLC is well-qualified to assist clients in responding to and defending against government investigations. We can counsel clients under investigation by the DOJ and others, including the Federal Bureau of Invesitgation, Food and Drug Administration, HHS-OIG, Fiscal Intermediaries, Recovery Audit Contractors, Medicaid Fraud Control Units and State Attorney General Offices.  These investigations could involve allegations of billing for medically unnecessary services, billing for services not rendered, double-billing, unbundling, upcoding, off-label marketing, device misbranding, illegal kickbacks, violations of the Stark self-referral law, HIPAA privacy violations, wrongdoing during clinical research or violations of the Prescription Drug Marketing Act.  Many of these investigations may involve both a civil and criminal component, might span multiple years and require the review and production of hundreds of thousands of documents.  Needless to say, such protracted investigations can be a financial and reputational drain on a company.  We can assist clients in attempting to resolve these investigations early enough in the process to mitigate these harms, with the aim of achieving a favorable settlement, or even obtaining a finding of no liability.  If such efforts fail, Kaiser Law Firm, PLLC stands ready to litigate.

Physician Compensation and Financial Arrangements

Kaiser Law Firm, PLLC can advise clients on the complex legal requirements that apply to the financial relationships between institutional providers and physicians, between physicians and other individual medical providers and between all types of medical providers and the vendors with whom they do business.  Such relationships are subject to federal and state anti-kickback and self-referral laws, and must comply with those legal mandates.  Moreover, since the rules governing fraud and abuse continue to evolve as new laws are passed, new regulations are promulgated, new cases are tested in the courts, and new government settlements take place, ongoing reviews of new and existing contractual and financial relationships is essential.

Regulatory Due Diligence

Kaiser Law Firm, PLLC is able to assist clients in performing regulatory due diligence for merger, acquisition and financing transactions. For acquiring companies, venture capital firms, lenders and underwriters, we can apply our regulatory knowledge and investigative experience to help assess the health care fraud and abuse risks of target companies.  We can look at issues such as licensure, certification, coverage and reimbursement, billing and coding, marketing and financial relationships with physicians and other referral sources (anti-kickback and Stark law compliance) to evaluate a target’s compliance with applicable laws, rules and regulations. After assessing a target’s regulatory risks, we can then communicate those risks to our clients.

White Collar Criminal Defense

Kaiser Law Firm, PLLC is well-qualified to represent clients facing criminal health care fraud allegations.  We have extensive experience with health care investigations and are sensitive to the impact government investigations and criminal charges have on both individual and corporate clients.  Kaiser Law Firm, PLLC can represent clients before a grand jury, respond to grand jury and administrative subpoenas and civil investigative demands, prepare voluntary disclosures and negotiate settlements with both federal and state prosecutors.  When a criminal charge cannot be avoided, we have the knowledge and experience that is required to negotiate the most favorable plea agreement possible or, if need be, to defend against those allegations at trial.