Regulatory Issues

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Jane Drummond

General Counsel and Senior Vice President of Governmental Relations

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Health Care Regulations & Compliance

Regulations shape how hospitals and health systems operate, impacting compliance, patient care and financial sustainability. MHA provides updates, guidance and resources to help Missouri hospitals navigate evolving regulatory requirements at the state and federal levels. By remaining informed, hospital leaders can ensure compliance, mitigate risks and advocate for policies that support effective health care delivery.

Our resources for hospital administrators, compliance officers and health care advocates provide clarity on the latest regulatory updates, changes in reporting requirements and best practices for meeting compliance standards. Understanding these regulatory frameworks ensures that hospitals remain compliant while adapting to changes that affect health care delivery.

Stay Informed on the Latest Regulatory Updates

Access the most up-to-date state and federal regulatory resources to ensure compliance.

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Federal Health Care Regulations
State Health Care Regulations

Federal Health Care Regulations

Federal regulations set nationwide standards that Missouri hospitals must follow, impacting areas such as reimbursement policies, patient safety and health information security. These regulations are established by agencies including:

Centers for Medicare & Medicaid Services (CMS) – Oversees Medicare and Medicaid reimbursement policies and hospital compliance requirements
U.S. Department of Health & Human Services (HHS) – Establishes federal health policies, patient privacy protections and funding regulations
Food & Drug Administration (FDA) – Regulates pharmaceuticals, medical devices and public health safety measures affecting hospitals

MHA actively monitors federal regulatory changes and provides our member hospitals with resources to navigate new requirements, ensuring hospitals remain compliant while delivering high-quality care.

Key Federal Regulatory Updates

Why This Matters

CMS released a final rule on discharge planning, requiring hospitals to ensure that patients make informed decisions about their post-acute care options. This regulation strengthens care coordination, patient autonomy, and continuity of care, helping hospitals reduce readmission rates and improve patient outcomes.
What Hospitals Need to Do
- Ensure that discharge planning aligns with patient goals and treatment preferences
- Implement interoperability measures to facilitate the seamless exchange of health information between care settings
- Update hospital discharge policies and procedures to comply with the new CMS requirements
Regulatory Details
- Published in the Federal Register: Sept. 27, 2019
- Effective Date: Nov. 26, 2019
- Conditions of Participation (CoPs) Updated: Feb. 21, 2020
- Interpretive Guidance Status: Pending publication
View MHA’s Issue Brief
View the CMS Rule Summary
View the Rule
Why This Matters

CMS finalized interoperability and patient access requirements to ensure patients have timely and secure electronic access to their health information. These changes improve care coordination, transparency, and data-sharing across health systems, benefiting providers and patients.
What Hospitals Need to Do
- Implement Patient Access API and Provider Directory API policies for Medicare Advantage, Medicaid and CHIP
- Ensure compliance with 42 CFR Parts 482 and 485 for electronic data-sharing requirements
- Prepare for full enforcement of new Qualified Health Plan issuer requirements for the individual market
Regulatory Details
- Final Rule Published: March 9, 2020
- CoPs Effective Date: Initially six months after publication, later extended to 12 months post-publication (May 1, 2021)
- Patient Access API & Provider Directory API Effective Date: Jan. 1, 2021
- CMS Enforcement Discretion Ended: July 1, 2021
View the CMS Final Rule on Interoperability
ADT Notification CoPs – Final Rule CMS Guidance & FAQs
Hospitals must comply with Admission, Discharge and Transfer (ADT) notifications under CMS’ interoperability rule. This webinar, featuring health care and HIPAA attorney Helen Oscislawski, provides an overview of compliance requirements, operational considerations and available tools.
View the Webinar
CMS Listening Session: Promoting Interoperability
This Medicare Learning Network session covers the impact of CMS’s new interoperability requirements, detailing prior authorization processes and electronic patient data access. The session includes an audio recording, transcript and clarification resources.
Listen to the Session
View the Transcript
Why This Matters

CMS introduced the Omnibus Burden Reduction Final Rule to eliminate outdated and unnecessary Medicare regulations. This rule reduces administrative burdens on hospitals and streamlines compliance processes. These changes promote efficiency, transparency and regulatory flexibility, enabling hospitals to focus on patient care.
What Hospitals Need to Do
- Review updated Conditions of Participation to ensure compliance with revised federal requirements
- Adjust operational protocols to align with new flexibility measures for hospitals and critical access hospitals
- Implement fire safety standard updates for dialysis facilities as required by CMS
Regulatory Details
- Published in the Federal Register: Sept. 27, 2019
- Effective Date: Nov. 26, 2019
- CoPs Updated: Feb. 21, 2020
- Interpretive Guidance Status: Pending publication
View MHA’s Issue Brief
View the Rule
Why This Matters

MHA is actively advocating for clarity in sepsis diagnosis and reimbursement policies. While CMS continues to reimburse claims based on Sepsis-2 criteria, commercial payers increasingly deny claims, citing noncompliance with Sepsis-3, which requires end-organ failure. This inconsistency creates financial and operational challenges for hospitals.
What Hospitals Need to Do
- Review sepsis documentation and coding practices to minimize reimbursement denials
- Stay informed on Sepsis-3 policy discussions and potential regulatory changes
- Engage with MHA advocacy efforts to support fair and consistent sepsis reimbursement standards
Download the Letter on Sepsis-3 Definition
Download the Letter on Sepsis Coding Changes
Download the Letter on Sepsis Denials
Why This Matters

USP standards guide sterile compounding practices and hazardous drug handling, ensuring patient safety and regulatory compliance. Delays in new standards create uncertainty for hospitals, making it essential to stay informed and prepared for future updates.
What Hospitals Need to Do
- Continue following the 2008 USP <797> standards for sterile compounding until further notice
- Prepare for possible revisions to USP <797> following the resolution of pending appeals
- Implement USP <800> hazardous drug handling standards to minimize risk exposure for staff and patients
Download MHA USP <797> Information
Download MHA USP <800> Information

State Health Care Regulations

Key State Regulatory Updates

Why This Matters

As of July 2022, 988 is the national three-digit phone number for mental health, substance use and suicide crises. While this number is available nationally, each state is responsible for ensuring that crisis services are adequately funded and available. In Missouri, the 988 Task Force is developing a long-term implementation plan to sustain and expand crisis response services.
What Hospitals Need to Do
- Stay informed on 988 policies and funding developments in Missouri
- Educate staff on how to direct patients and families to 988 crisis services
- Use available Substance Abuse and Mental Health Services Administration toolkits to integrate 988 messaging into hospital communications for communities and staff
- Download and attach the QR code to link directly to the Missouri Department of Mental Health’s website for relevant 988 correspondence
View Crisis Lifeline FAQs
View the SAMHSA 988 Toolkit
Watch the 988 Implementation Webinar
Learn More About Behavioral Health Care
Sexual Assault Forensic Examination Regulations
Why This Matters

In 2020, Missouri enacted Senate Bill 569, introducing new requirements for hospitals providing forensic examinations for sexual assault survivors. The legislation establishes rights for survivors, mandates tracking of sexual assault kits and ensures compliance with updated forensic standards.
Key Provisions Impacting Hospitals
- 192.2520 & 197.135 – Justice for Crime Survivors: Outlines hospital obligations in providing forensic exams
- 595.201 – Sexual Assault Survivors Bill of Rights: Guarantees rights and resources for survivors
- 595.202 – Missouri Rights of Victims of Sexual Assault Task Force: Ensures ongoing policy review
- 595.220 – Electronic Tracking of Sexual Assault Kits: Requires law enforcement and hospitals to track evidence
What Hospitals Need to Do
- Ensure compliance with new forensic examination protocols
- Educate medical staff on survivor rights and procedural requirements
- Implement electronic tracking systems for sexual assault kits
Download Senate Bill 569
View Survivors Bill of Rights
Learn More About Trauma-Informed Care
Why This Matters

In 2020, Missouri enacted Senate Bill 569, introducing new requirements for hospitals providing forensic examinations for sexual assault survivors. The legislation establishes rights for survivors, mandates tracking of sexual assault kits and ensures compliance with updated forensic standards.
Key Provisions Impacting Hospitals
- 192.2520 & 197.135 – Justice for Crime Survivors: Outlines hospital obligations in providing forensic exams
- 595.201 – Sexual Assault Survivors Bill of Rights: Guarantees rights and resources for survivors
- 595.202 – Missouri Rights of Victims of Sexual Assault Task Force: Ensures ongoing policy review
- 595.220 – Electronic Tracking of Sexual Assault Kits: Requires law enforcement and hospitals to track evidence
What Hospitals Need to Do
- Ensure compliance with new forensic examination protocols
- Educate medical staff on survivor rights and procedural requirements
- Implement electronic tracking systems for sexual assault kits
Download Senate Bill 569
View Survivors Bill of Rights