Healthcare Compliance Program Policies and Procedures
Healthcare compliance program policies and procedures should consist of a combination of policies and procedures mandated by federal, state, and local regulations, and policies and procedures implemented in response to a risk assessment or other corporate activity. There are no “one-size-fits-all” policies and procedures for healthcare compliance programs.
Healthcare compliance programs are essential for ensuring organizations comply with all federal, state, and local regulations applicable to their activities, industry best practices, and voluntary standards. Key to the effectiveness of a healthcare compliance program are policies and procedures that instruct workforce members how to perform their functions within the boundaries of the program and how to respond to specific events.
Most federal, state, and local regulations have policy and procedure requirements. However, while some are direct requirements, others are indirect requirements. For example, in the HIPAA Privacy Rule there is only one direct requirement – to implement policies and procedures limiting requests for, and disclosures of, Protected Health Information (PHI) to the minimum necessary. But there is also an indirect requirement in §164.530(i)(1) to:
“[…] implement policies and procedures with respect to PHI that are designed to comply with the standards, implementation specifications, or other requirements of this subpart [the Privacy Rule] and subpart D of this part [the Breach Notification Rule]. The policies and procedures must be reasonably designed, taking into account the size and the type of activities that relate to PHI undertaken by a covered entity, to ensure such compliance.
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It is Not Necessary to Implement a Policy for Every Standard
In the context of implementing healthcare compliance program policies and procedures to comply with this standard, it is important to be aware that §160.304 of the HIPAA General Rules requires covered entities and business associates to comply with the “applicable administrative simplification provisions” (HIPAA Parts 160, 162,and 164). Therefore, it is not necessary to implement policies and procedures for every standard in the Privacy and Breach Notification Rules.
It is different for organizations required to comply with the Security Rule, as the Security Rule contains twenty-one direct requirements to implement policies and procedures in addition to the indirect “catch-all” standard §164.316, which requires covered entities and business associates to “implement reasonable and appropriate policies and procedures to comply with the standards, implementation specifications, or other requirements of this subpart”.
However, the language of this standard (“reasonable and appropriate”) complicates the development of Security Rule policies and procedures. Whereas policies to comply with the Privacy Rule might state members of the workforce can only disclose PHI in A, B, or C circumstances – and procedures following a data breach are D, E, and F – the Security Rule’s “flexibility of approach” can make it difficult to determine the content of healthcare compliance program policies and procedures.
Where to Start with Healthcare Compliance Program Policies and Procedures
The indirect requirement to implement policies and procedures for the Privacy Rule, and the flexibility of approach with regards to Security Rule policies and procedures demonstrate how difficult it can be to develop and implement effective healthcare compliance program policies and procedures. In addition, the only regulation mentioned to date has been HIPAA.
When a healthcare compliance program also includes (for example) OSHA standards, the conditions for participation in Medicare, PCI DSS compliance, and state privacy regulations, developing, implementing, training members of the workforce on, and monitoring compliance with a multitude of policies and procedures can be beyond the capabilities and resources of an organization.
The solution to this issue is to take advantage of customizable healthcare compliance software or outsource the organization’s compliance obligations – or use a combination of both – to develop healthcare compliance program policies and procedures before taking back the reins to manage workforce training and compliance monitoring. Most organizations looking to start a healthcare compliance program will find this the most cost-effective program.
There are a number of software vendors and compliance experts who can support an organization looking to start a healthcare compliance program by helping with the development and implementation of policies and procedures. Our advice is to take advantage of demos, free trials, and no-obligation consultations to evaluate these solutions in the organization’s own environment and determine which solution(s) best meets an organization’s requirements.
