What is medical compliance?

 


At a glance

  • Healthcare compliance is the practice of adhering to federal healthcare laws and regulations.
  • Compliance laws are intended to help protect patients, safeguard sensitive information and help mitigate and prevent fraud, abuse and waste in the healthcare industry.
  • Noncompliance poses serious risks to patients and can result in legal action.

Global healthcare is a trillion-dollar industry that focuses on the safety and care of patients. In the U.S., compliance in healthcare is of the utmost importance due to the sheer size of the industry, the risks associated with it and its dynamic nature. These factors open up the possibility of fraud and abuse, and this is where healthcare compliance comes in.

Healthcare compliance is the practice of adhering to federal healthcare laws and regulations, which prohibit and prevent fraud, abuse and waste in the healthcare industry. It’s founded on ethical standards for patient treatment.

Learn what healthcare compliance is, what the laws are and how to ensure a healthcare facility complies.

Healthcare compliance laws

Many laws regulate the healthcare industry. While the following isn’t an exhaustive list of laws and regulations, these are some important ones:

  • Health Insurance Portability and Accountability Act (HIPAA): Protects private patient information from being shared without a patient’s knowledge or consent.
  • Health Information Technology for Economic and Clinical Health (HITECH) Act: HITECH expands the scope of HIPAA and provides healthcare facilities with certain standards for using IT to implement electronic health records (EHR).
  • Emergency Medical Treatment & Labor Act (EMTALA): This law was enacted to ensure the public can access emergency treatment regardless of whether they can pay.
  • Patient Safety and Quality Improvement Act (PSQIA): This law was enacted to encourage the reporting, discussion and resolution of patient safety issues. It also authorizes the Agency for Healthcare Research and Quality to provide a database of Patient Safety Organizations (PSOs).
  • Anti-Kickback Statute: A statute that prohibits providers and organizations from receiving financial incentives for a patient referral when the federal government may be charged for those services.
  • False Claims Act (FCA): Under the FCA, filing a false claim for federal program funds is illegal and punishable with fines from $11,803 to $23,607.

These laws are in place primarily to protect patients and ensure that all individuals have equitable access to healthcare in the U.S.

Who is responsible for healthcare compliance?

Everyone in a healthcare organization must adhere to the healthcare regulations established by the government. It’s the responsibility of every professional to make sure they are acting ethically and per all laws. Many healthcare organizations have a compliance officer, or a similar role, to help ensure the facility is compliant.

  • Department of Health and Human Services (DHS): A federal agency focused on improving the health, safety and well-being of every American.
  • Drug Enforcement Administration: A federal government agency tasked with combating drug trafficking and distribution in the U.S., including prescription drugs.
  • The Joint Commission: A not-for-profit institution that introduced a standard for accreditation of healthcare organizations in the U.S.
  • Office of the Inspector General: An office within the U.S. Department of Health and Human Services whose mission is to protect the integrity of DHS programs through audits and investigations.
  • Food and Drug Administration (FDA): An entity that regulates the information that must be included and disclosed on prescription drugs. The FDA also approves or disapproves prescription drugs to be used in healthcare.

These entities can provide resources and guidance on any healthcare compliance issues you might encounter.

The importance of compliance in healthcare

A compliance program in healthcare is important for many reasons. For starters, the stakes are high. Healthcare compliance is meant to help prevent fraud or abuse of patients.

Healthcare compliance and regulations also protect patient privacy and safety and encourage healthcare professionals to provide high-quality care to all patients. It also dictates how to bill patients properly. Not only do compliance program regulations protect people, but they also protect valuable information.

Complying with health information technology laws and regulations can help protect against any potential data breaches or cybersecurity threats.

Adhering to the federally instated laws and regulations allows a healthcare organization to protect its patients and become a credible organization.

COMPLIANCE

FOCUS AREA WORKING GROUP

The goals of the Medical Affairs Professional Society Compliance Focus Area Working Group are to create a community that advances our role as fully integrated strategic business partners to promote the growth of Compliance and Medical Affairs Professionals within the life sciences sector worldwide; to develop our Compliance community within MAPS to become the premier global destination of choice for Compliance and related Medical Affairs Professionals, noting the synergies and close working relationships across the teams; and to catalyze our individual personal leadership development and professional career advancement. ​

Activities:

We will organize Compliance-related workshops for MAPS meetings in the North America, APAC (Asia Pacific – China/Japan), and EMEA (Europe, Middle East, Asia) regions. We develop original content for webinars, podcasts, eLearning courses and white papers. In addition, the working group will periodically contribute cogent and timely content on the Compliance sector for the MAPS publication, Elevate magazine. Most importantly, we will provide a supportive resource for all Compliance and related Medical Affairs Professionals. ​

Strategic Objectives

  1. Educate & Inform: Provide timely, relevant content on effective and compliant information exchange in the current regulatory environment
  2. Engage: Drive robust insightful dialogue among medical affairs professionals and between MA professionals and their commercial, compliance and other colleagues
  3. Guide: Provide guidelines, tools and solutions to Medical Affairs professionals to help them to design and execute compliant information exchange

To know more visit: https://medicalaffairs.org/compliance/

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