Compliance and Regulatory Considerations: Ensuring your Chronic Care Management Software Meets Standards

Care manager monitoring patient vitals on HIPAA-compliant CCM Software

Did you know the Department of Human and Health Services (HHS), in 2021, fined $135.3 million in penalties for violating regulatory compliances in virtual care?

Well, this is not the first time HHS has fined healthcare practices. In fact, in 2018, for violating HIPAA compliance, HHS fined penalties worth $28 million. As the adoption rate of virtual care increases, more healthcare data will be prone to data security threats.

To avoid such complications, HHS, the Center for Medicare and Medicaid Services, and other regulatory bodies have set some compliances and regulations for healthcare providers to imbibe ethical and efficient healthcare practices.
Since chronic care management is one of the most complex programs initiated by CMS, its regulations and compliances can be equally complicated.
Abiding by these regulations and compliances is necessary to navigate through the legalities smoothly and also add another layer of security for the patient data you store and manage.

In this blog, let’s see what the key regulatory compliances for your chronic care management software are and how to navigate smoothly through the regulatory landscape.

Key Regulatory Standards

There are four major key regulatory standards that you are bound to follow to develop robust chronic care management software. Let’s discuss that in detail below:

1. Medicare’s Chronic Care Management Service Code:

Medicare Part B covers 80% of the reimbursement, so they are bound to put some regulatory standards in place for your healthcare practice. Specific CPT codes have been assigned for specific healthcare services provided by the care manager.
Medicare Part B covers 80% of the reimbursement, so they are bound to put some regulatory standards in place for your healthcare practice. Specific CPT codes have been assigned for specific healthcare services provided by the care manager.

This means the chronic care management software should support and include CPT codes practice for billing. Below are the CPT codes dedicated to the CCM program as per complex and non-complex chronic conditions:

Non-complex

  • 99490
  • 99439

Complex

  • 99487
  • 99489
  • 99491
Along with that, the CCM software should also support ICD 10 codes, which makes it easier for everyone involved in the care delivery process to identify specific diseases and diagnoses.

2. HIPAA and Protected Health Information (PHI) Requirements:

HIPAA stands for Health Insurance Portability and Accountability Act, which was enacted in 1996 to safeguard sensitive patient health information from healthcare providers. It is regulated by the Department of Health and Human Services (HHS) and enforced by the Office of Civil Rights (OCR).
Ensuring HIPAA compliance in CCM software is important because it will contain sensitive PHI; apart from patient demographic details, it contains the patient’s social security numbers, medical records, etc. If this information is accessed for wrongful practice, it directly compromises the fundamental rights of the individuals, resulting in heavy fines and reputation damage.

Here are some important rules you can keep in mind during the chronic care management software development process:

    • The HIPAA Privacy Rule

 

    • The HIPAA Security Rule

 

    • The HIPAA Breach Notification Rule

 

    • The HIPAA Transaction Rule

 

    • The HIPAA Enforcement Rule

 

    • The HIPAA Identifiers Rule

 

  • The Omnibus Rule
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3. Meaningful Use and Interoperability Standards

Managing chronic conditions is a collaborative effort of the entire care team. In the virtual care space, your CCM software needs to communicate and exchange information with other healthcare systems.
Establishing a connection with different healthcare systems is fairly easy. However, the software should be able to interpret the healthcare information properly and accurately. This is where interoperability comes into the picture. Since every healthcare system uses different standards, the system finds it difficult to interpret and present data accurately. It can have a devastating effect on patient health.
Following interoperability standards like FHIR, HL7, etc, can be an effective way to maintain consistency and a standardized flow of information and data between disparate healthcare systems.

4. Additional State and Regulatory Considerations:

Other than all the necessary regulations mentioned above, your healthcare practice should comply with the state-regulated necessary compliance standards. For instance, few states require you to hold specific certifications like HITRUST or SOC2.

Apart from that, in 2023, the states of Colorado, Hawaii, and Nevada passed new payment parity requirements. Click here to read about them in detail.

Another state-specific requirement that you should consider is telehealth licensure legislation, which was introduced and passed in 20 different states in the United States, such as Idaho, Oregon, Virginia, Louisiana, Utah, and Vermont.

Choosing Compliant CCM Software

When choosing a compliant chronic care management software, it is important to understand the features that it provides. As features define the functionality of the software, a keen interest in its functions can help you streamline compliance with best practices. This way, you will not only get an idea about the functioning of the software but also bridge the compliance gaps if there are some left to address.

You can get an idea of whether the software is compliant by checking its data storage type. Since most of the CCM software nowadays uses cloud-based data storage for security, it majorly solves the security problems.

Along with that, audit trails and automated reporting features can give you even deeper insight into the activity of the software. While audit trails can ensure authorized access to patient health data, automated reporting can maintain transparency in the practice.

However, if you are going ahead with a custom chronic care management software development, then evaluating vendor compliance practices can prove to be crucial. It is recommended to discuss the strategies vendors implement to achieve compliance and data security.

Despite all this, understand that the technological landscape is changing, and that is forcing the regulatory bodies to update on a regular basis. Staying up-to-date with the updates can ensure the software is always compatible and compliant.

Implementing Compliance Best Practices

To help you understand the best practices that you can implement to ensure the software complies with the regulatory requirements, here are a few best practices that you can follow:
  • Effective Training and Education: For optimum and correct use of the software, it is important to provide effective training and education to the users. Provide hands-on training to the healthcare staff, including providers, about data management, documentation, and the necessary security protocols.

  • Conduct Regular Internal Audits: One of the best practices to check the proper functioning of the software is by conducting internal audits. The results will provide you with deeper insights into the software’s usability and identify potential breaches and problems in the software functionality. Maintaining
  • Documentation and Reporting: Along with education and internal audits, maintaining accurate documentation and reporting should be given equal importance. Since CMS requires detailed and accurate documentation of care plans, patient-provider encounters, patient consent, etc., it can help you comply with CMS regulations and streamline billing practices.

Conclusion

In the changing digital landscape, where data is considered to be the new-age currency, safeguarding it to maintain its integrity is crucially important. Especially in this rapidly changing digital healthcare landscape where everything seems to be interconnected, abiding by the compliances and regulatory requirements has been a necessity.

Let this compliance and regulatory guide help you navigate through the necessary requirements. This guide will help you in choosing the right CCM software and give you a brief overview of the necessary compliances that you need to prioritize.

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Free Guide to HIPAA-Compliant Chronic Care Management Software
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Frequently Asked Question’s

Here are some of the regulations you need to follow to make your CCM Software compliant:

  • Centers for Medicare & Medicaid Services (CMS) Guidelines
  • HIPAA (Health Insurance Portability and Accountability Act)
  • EHR Incentive Programs
  • State Licensing Regulations
  • Vendor-Specific Regulations

You can ensure HIPAA compliance for your CCM software by thoroughly reviewing vendor documentation and assessing security features like access control, data encryption, audit logs, incident response plans, etc. 

The patient’s protected health information can be generally collected and shared through the chronic care management software. This data usually consists of the patient demographics, billing information, medication history, medical history, etc.  

Failing to adhere to the compliances and regulations can result in heavy fines and reputation damage for the provider.

You can choose a CCM software with strong compliance practices by reviewing their compliance best practices and checking for their certifications.

It is not mandatory for your CCM software to have any certifications, but to generate trust and maintain integrity in practices, certifications like HIPAA, GDPR, HITECH, and CMS can be useful.
Constantly checking the CMS guidelines and laws specific to your location can help you in staying updated with any changes.
Technology can help in improving CCM software compliance by automatically checking compliances and conducting thorough audit trails to implement robust security measures. Along with that, it can also streamline workflow and reporting and improve the accuracy of checks.

Key regulations for chronic care management software are:

  • HIPPA (USA)
  • GDPR (European Union)
  • State Specific Regulations
  • CMS Regulations
  • HITECH

Here is how you can assess your CCM software compliance risk assessment:

  • Identify legal and regulatory requirements
  • Review and document current practices
  • Evaluate the risk
  • Prepare a risk management plan
  • Implement controls
  • Monitor and review

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