Healthcare Compliance Program Assessment, DevelopmenT & Design Services

Healthcare Compliance programs must be evaluated periodically to assess their effectiveness as a whole. Lack of healthcare compliance creates a gaping liability that no organization needs. Comprehensive changes are only effective if the management team is committed to implementation and enforcement. In the event of a regulatory investigation, thorough documentation of all aspects of the facility’s healthcare compliance program is necessary to demonstrate good faith and the program’s effectiveness.

MCRA’s healthcare compliance team has extensive experience assessing, developing and designing healthcare compliance programs for medical device companies. From startups through large corporations, MCRA provides a variety of services to keep your organization up to code. The Healthcare compliance program reviews and evaluates compliance issues and concerns within the organization relating to federal and state healthcare programs, and is designed to assure compliance with all laws, rules and regulations relating to these programs.

  • Our Healthcare compliance program assessment and design services include:

  • Strategic Healthcare Compliance Plan & Process

    Policies, Procedures and Code 
    of Conduct

    Healthcare Compliance & Business Ethics Training
  • Sanction Screening

    Patient Privacy

    Conflict of Interest Management


a. Strategic Healthcare Compliance Plan & Process Development
MCRA understands what companies need to comply with current laws and regulations. At MCRA, we follow legislative initiatives and take our time to understand all proposed and newly enacted legislation so we can understand how it will impact your business. MCRA’s team has the expertise to predict, create, and implement the strategic initiatives and operational services to maximize your company’s value by assisting in the development of an effective ethics and healthcare compliance program.

b. Policies, Procedures & Code of Conduct Development and Advisory
Today, business organizations of every type needs policies, procedures, and codes of conduct to detect, prevent, and remedy violations of law, regulations, and organization policies, and to demonstrate their commitment to ethical business practices. Creating and maintaining these programs is challenging for every company, from the single product manufacturer to complex global institutions.

MCRA creates policties, procedures, and codes of conduct to help you quickly catch problems and efficiently transition to implement a corrective plan of action. MCRA’s services includes the assessment and development of policies, procedures and codes of conduct, and employee training, to enable your company to function proficiently while simultaneously exercising your due diligence to avoid liability as much as possible.

  • MCRA’s Policies, Procedures and Code of Conduct services include:

  • Assessment
  • Development

c. Telephone Hotline Management
MCRA maintains confidential disclosure programs, including a toll-free telephone line and email service that allows employees to report suspected violations of federal or state health care program requirements or company policies and procedures. MCRA will also contribute appropriate content to company newsletters to ensure employees are informed about current healthcare compliance activities and are aware of the confidential reporting mechanisms.

d. Healthcare Compliance & Business Ethics Training
MCRA provides employee training that covers healthcare compliance policies, procedures and the pertinent legal requirements. The specific training will be tailored to your organization’s operating structure to make the time as meaningful as possible for each group of participants.

e. Patient Privacy
Federal and state laws, such as the Health Insurance Portability and Accountability Act of 1996 (HIPAA), provide guidance for patients regarding their privacy rights and the use or disclosure of their medical information. To ensure the development of a lasting bond of trust with your patients, we can help you implement safeguards to protect their personal information. From developing policies and procedures to hiring recommendations and training manuals, MCRA can help your organization understand the applicable laws and regulations, and then develop and implement effective processes and procedures to make your patients feel safe and comfortable.

f. Conflict of Interest Management
Management plans are created to proactively address questions that may arise regarding an individual's objectivity, integrity or professional commitment as a result of a disclosed activity, relationship or financial interest. Some federal funding agencies specifically require a management plan be developed and implemented when a financial conflict of interest is identified.

MCRA can help develop a management plan that addresses potential, perceived and actual conflicts of interest to swiftly implement the necessary actions.

To contact a healthcare compliance expert at MCRA, call 202.552.5800 or email

MCRA is not a law firm and neither provides legal advice to its clients nor can affirm the legal or regulatory validity of the materials of which it provides. MCRA recommends that its clients consult an attorney to discuss any legal issues that relate to its business and/or MCRA services

People & Expertise

Colleen Nelson, M.A., J.D.

Head of Healthcare Compliance

With over twenty years of experience in healthcare compliance, Ms. Nelson manages and directs the healthcare compliance and business ethics practice for MCRA. 
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PH: 202.552.5800