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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.

CMS

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.

access the memos

EMTALA

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.

HIPAA

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.

Telehealth

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.

MHA Resources

Contact an expert

Sarah Willson

Sarah Willson

Vice President of Clinical and Regulatory Affairs
Andrew Wheeler

Andrew Wheeler

Vice President of Federal Finance
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