Regulatory & Compliance
Compliance with health care rules, laws and regulations is the foundation upon which a trusting provider/patient relationship is built.
Complying with industry standards and regulations — mostly as it relates to patient safety, privacy and billing practices — helps hospitals provide safe, high-quality patient care.
Hospitals are required to be in compliance with the federal requirements set forth in the Medicare Conditions of Participation to receive Medicare/Medicaid payment. Acute care hospitals must show compliance with 42 CFR Part 482; critical access hospitals must be in compliance with 42 CFR Part 485. Hospitals also are subject to state hospital licensure rules. Resources and tools are available to assist hospitals in meeting these ever-changing requirements.
Medicare State Operations Manual
The Medicare State Operations manual contains information for hospitals on all aspects of Medicare compliance. Hospitals will find information on billing procedures, swing-bed criteria, survey processes and a host of other compliance-related information.
For a complete list of Medicare State Operations Manuals, see the Appendices Table of Contents, which specifically includes information on the requirements for certification and further explains those requirements, also known as the Interpretive Guidelines. These guidelines inform hospitals on how CMS surveyors will evaluate their compliance with the CoPs.
Below is a partial list of Appendices that MHA most frequently accesses when helping hospitals with regulatory and compliance questions.
- Acute Care Hospitals: Appendix A (Rev. 200, 2-21-20)
- Critical Access Hospitals: Appendix W (Rev. 200, 2-21-20)
- Determining Immediate Jeopardy: Appendix Q (Rev. 187, 3-6-19)
- Emergency Preparedness for All Provider and Certified Supplier Types: Appendix Z (Rev. 200, Issued: 2-21-20)
- Intermediate Care Facilities for Individuals with Intellectual Disabilities: Appendix J (Rev. 178, 04-13-18)
- Life Safety Codes: Appendix I (Rev. 159, 09-09-16)
- Outpatient Physical Therapy or Speech Pathology Services: Appendix E (Rev. 119, 07-25-14)
- Responsibilities of Medicare Participating Hospitals In Emergency Cases: Appendix V (Rev. 191, 07-19-19)
Policies and Memos
CMS Quality Safety & Oversight memoranda, guidance, clarifications and instructions to State Survey Agencies and CMS Regional Offices inform states and hospitals on changes or modifications to conditions and other policies before those changes typically appear in a revision of the conditions manuals and appendices. Checking the website frequently is an effective way to stay abreast of the latest changes. MHA compiled some of the most recent memos impacting hospitals.
The Emergency Medical Treatment & Labor Act ensures that the public has access to emergency services, regardless of a person’s ability to pay for medical services. CMS released revisions to Appendix V, Part II, EMTALA Interpretive Guides.
The Health Insurance Portability and Accountability Act, better known as HIPAA, protects individuals’ health information from inappropriate uses or disclosures. The law establishes standards for the release of protected health information by covered entities, which include health care providers, health plans, and health care clearinghouses (such as medical billing services). Protected health information includes medical information in both printed and electronic form. In addition to the privacy rule which governs the disclosure of protected health information, HIPAA security regulations require covered entities to maintain certain physical plant and electronic standards to guard against inappropriate access to PHI. For a summary of the HIPAA Privacy Rule, visit the U.S. Department of Health & Human Services website.
State Hospital Licensure and Regulatory Standards
In Missouri, the Medicare Conditions of Participation serve as the baseline licensure standards for state hospital licensure. Chapter Section 197.005, RSMo, states compliance with Medicare CoPs shall be deemed to constitute compliance with the standards for hospital licensure under sections 197.010 to 197.120 and regulations promulgated thereunder. The state, under the statute, may create additional regulations so long as they are not duplicative or contradictory to the conditions.
The Missouri Department of Health and Senior Services hospital licensure regulations can be found at 19 CSR 30-20. While the regulations under Chapter 20 pertain to licensure standards, they are not the only regulations that apply to hospital operations. Missouri hospitals also must comply with communicable disease reporting, abortion, medical marijuana, child abuse and neglect, peer review, and a whole host of other state laws and regulations.
The Missouri Department of Commerce and Insurance oversees the professional licensing boards of many professions employed by hospitals. The Division of Professional Registration resides within the department. Below are links to regulations for some of the professions employed by hospitals.
Physicians and Surgeons
Most Missouri hospitals care for patients who have experienced some form of trauma or who are displaying signs and symptoms consistent with a cardiac emergency like stroke or heart attack. Many hospitals have taken steps to adhere to certain principles of care and go through additional survey and designation processes to become trauma, stroke or STEMI centers. Hospitals collaborate with one another and EMS throughout the state to ensure patients receive the right care, at the right time, in the right place.
TCD State Statutes
Technology has the power to transform health care, and one area experiencing unprecedented growth is telehealth. MHA is working with federal, state and local providers to ensure telehealth is a viable option for use by hospitals. Policy considerations for reimbursement, workforce and staffing, broadband access, and regulatory oversight are among our top telehealth priorities.
- Missouri Telehealth Network
- CMS Medicaid Telemedicine Website
- Health Resources & Services Administration Telehealth
Toolkits & Publications
- CMS: General Provider Telehealth and Telemedicine Toolkit
- CMS: Telehealth Services Booklet
- AHRQ: How to Obtain Consent for Telehealth | Sample Telehealth Consent Form
MHA has developed self-assessment checklists for acute care hospitals and critical access hospitals that will aid them with their internal assessments of their compliance with state hospital licensure regulations, Medicare Conditions of Participation for hospitals, and the interpretative guidelines to the CoPs. These tools may help hospitals improve staff knowledge of the regulations, decentralize the responsibility for regulatory compliance from the administrative offices to all department managers. In addition, these tools will help staff proactively identify and correct regulatory issues to improve compliance and decrease the number and length of surveys and cited deficiencies.
The MHA Survey Manual: A Guide to the Licensing and Certification Survey Process has been created to help hospital leaders prepare for and understand the federal and state hospital survey process. The manual provides tips on how to prepare for surveys, interact with surveyors, write plans of correction, and avoid or appeal adverse actions.
This resource is for MHA members.
The Quality Assurance/Performance Improvement Guide is designed to help key hospital leaders recognize and understand the major components of the QAPI initiative and to support your organization’s quality improvement efforts. The QAPI Guide is primarily designed for professionals who are new to their current position, organization or level of responsibility.
- Workplace Violence Regulatory Considerations (Jan. 4, 2023)
- Hospital Waivers and Variances (Nov. 4, 2022)
- Civil Involuntary Commitment Notarization Requirements (Oct. 5, 2022)
- SAFETrack (Aug. 15, 2022)
- Hospital Visitation (Sept. 21, 22)
MHA created a resource guide for Hospital Signage Requirements, which includes information on types of signs; who must comply; the description of the requirement; and the location, language and font size for the sign.
- Restraint and Seclusion Crosswalks
- Required Orientation and Education Crosswalks
- Hospitals Waivers and Variances (March 2023)
- Hospital Self-Report and Complaint Toolkit (April 2022)
- UAP Toolkit (May 2021)
MHA has developed a number of webinars to help members understand certain state and federal regulatory requirements. To view all on-demand education related to Regulatory & Compliance topics, visit the Media Library.
The End of the PHE: Understanding the Level I and Level II PASRR Process
Date: May 2, 2023
The Missouri Hospital Association and the Missouri Health Care Association hosted a member webinar event on the Pre-Admission Screening and Resident Review process that will resume with the end of the public health emergency. The waiver that allowed nursing homes to admit new residents who have not received PASRR Level I screenings and Level II evaluations terminated on May 11, 2023.
Prognosis: A Case of Diversion
Date: March 29, 2022
MHA and HSG provide an overview of the regulatory environment impacting diversion policies and procedures. The decision to go on diversion can be a difficult one due to the impact on patients, community partners and hospital compliance. Speakers present several case studies to help participants apply regulatory requirements.
Work Leave for Domestic or Sexual Violence
Date: Oct. 26, 2021
A new Missouri law — Victims Economic Safety and Security Act — provides employees with unpaid protected time to seek certain services if they, or a family or household member, experience sexual or domestic violence. Employers with at least 20 employees must provide employees with notice of their rights using a form developed or approved by the Missouri Director of the Department of Labor and Industrial Relations. Join MHA staff to understand the requirements of the new law.
CMS Return of Survey Activity
Date: July 30, 2020
The Missouri Department of Health and Senior Services Bureau of Hospital Licensure and Standards will be resuming survey activity in hospitals for “High Non-IJ” reasons. CMS has authorized state agencies to begin to resume survey activity when they believe they can do so safely. The department will discuss departures from routine survey activity and how the process will look different due to the pandemic response.