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Survey & Certification Group: Emergency Preparedness Rule
"On September 8, 2016 the Federal Register posted the final rule Emergency Preparedness Requirements for Medicare and Medicaid Participating Providers and Suppliers. The regulation goes into effect on November 16, 2016." The purpose of this rule is "To establish national emergency preparedness requirements to ensure adequate planning for both natural and man-made disasters, and coordination with federal, state, tribal, regional and local emergency preparedness systems. This page provides additional information, such as the background and overview of the final rule and related resources.
Centers for Medicare & Medicaid Services (U.S.)
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Healthcare Payer Strategies to Reduce the Harms of Opioids
"Prescription opioid misuse and opioid use disorder (OUD) are significant and growing public health problems in the United States (U.S.) that impact stakeholders across the healthcare sector, including private, employer-sponsored, and public health plans.(1-4)[1] Healthcare payers (herein, payers), employer organizations, and law enforcement all have strong motivations to combat the inappropriate prescribing of opioids to improve patient health and reduce expenditures for medically unnecessary services and therapies. These are largescale problems for which payers play a critical role in reducing fraud, waste, and abuse while ensuring access to medically necessary therapies. Payers can help to combat the opioid crisis by identifying and sharing strategies, such as reimbursement and coverage policies, conditions for provider plan participation, and dissemination of information to a variety of audiences, to address the large-ranging issues that lead to fraud, waste, and abuse in the healthcare system. Such interventions are particularly suited to payers due to their relationships with providers of healthcare services, pharmacies, insured patients, employers, and law enforcement (in cases where potential fraud is identified). Payers collect and administer a large amount of healthcare information that can be used to identify and intervene on behalf of patients at risk of opioid-related harm, as well as to target fraud, waste, and abuse in opioid prescribing."
Centers for Medicare & Medicaid Services (U.S.)
2017-01
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Centers for Medicare & Medicaid Services (CMS) Opioid Misuse Strategy 2016
"Many Medicare and Medicaid beneficiaries and their families have experienced opioid use disorder, commonly referred to as addiction. Given the growing body of evidence on the risks of misuse, highlighted by the recently published guidance from the Centers for Disease Control (CDC), and the Administration's commitment to combatting the opioid epidemic, CMS [Centers for Medicare & Medicaid Services] is outlining our agency's strategy and the array of actions underway to address the national opioid misuse epidemic. Strategies outlined in this paper do not include CMS's vision for the treatment of cancer and hospice patients. Treatment of patients in these situations requires careful medical supervision based on therapeutic goals, ethical considerations, and the balance of risks and benefits of opioid therapy. Opioid drugs can treat both acute and chronic pain. While these types of drugs, including fentanyl, hydrocodone, hydromorphone, meperidine, methadone, morphine, oxycodone, and oxymorphone, can have benefits for many patients with serious pain-related conditions, these drugs cause serious and substantial harm when used improperly. Even when used as directed, they contribute to overdose or lead to development of substance use disorder in some individuals. The high potential for misuse of opioids have led to alarming trends across the United States, including record numbers of people developing opioid use disorders, overdosing on opioids, and dying from overdoses. Opioid misuse places Americans at an elevated risk for heroin use, overdose, and death. Use by injection places them at risk for exposure to blood borne diseases, including HIV and Hepatitis C."
Centers for Medicare & Medicaid Services (U.S.)
2017-01-05
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Guidance Related to the Emergency Preparedness Testing Exercise Requirements- Coronavirus Disease 2019 (COVID-19)
From the Memorandum Summary: "[1] 'Emergency Preparedness Testing Exemption and Guidance' - CMS [Centers for Medicare & Medicaid Services] regulations for Emergency Preparedness require specific testing exercises be conducted to validate the facility's emergency program. During or after an actual emergency, the regulations allow for an exemption to the testing requirements based on real world actions taken by providers and suppliers. [2] This worksheet presents guidance for surveyors, as well as providers and suppliers, with relevant scenarios on meeting the testing requirements in light of many of the response activities associated with the COVID-19 [coronavirus disease 2019] Public Health Emergency (PHE)."
Centers for Medicare & Medicaid Services (U.S.)
2020-09-28
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Interim Final Rule (IFC), CMS-3401-IFC; Requirements and Enforcement Process for Reporting of COVID-19 Data Elements for Hospitals and Critical Access Hospitals
From the Memorandum Summary: "[1] CMS [Centers for Medicare & Medicaid Services] is committed to taking continuing to take critical steps to ensure America's healthcare facilities are prepared to respond to the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (PHE). [2] On September 2, 2020, an interim final rule with comment period (IFC) went on display in the Federal Register. [3] CMS has released new regulatory requirements for all hospitals and critical access hospitals hospital (CAHs) at §42 CFR 482.42(e) and 485.640(d), respectively to report information in accordance with a frequency and in a standardized format as specified by the Secretary during the PHE for COVID-19. [4] Failure to report the specified data needed to support broader surveillance of COVID-19 may lead to the imposition of the remedy to terminate a provider's participation from the Medicare and Medicaid programs."
Centers for Medicare & Medicaid Services (U.S.)
2020-10-06
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Toolkit on State Actions to Mitigate COVID-19 Prevalence in Nursing Homes [March 2021, Version 20]
From the Objective: "This toolkit catalogs the many innovative solutions designed at the state level to protect our nation's vulnerable nursing home residents during the Coronavirus disease 2019 (COVID-19) pandemic. Beginning in October 2020, the toolkit includes up-to-date information, guidance, and innovative programs designed to increase vaccine use against influenza virus, pneumococcus (bacterium), and SARS-CoV-2 [severe acute respiratory syndrome coronavirus 2], the virus that causes COVID-19."
Centers for Medicare & Medicaid Services (U.S.)
2021-03
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Disaster Preparedness Toolkit for State Medicaid Agencies
"Medicaid has played a critical role in helping states and Territories respond to public health crises and natural and human-made disasters such as hurricanes (e.g., Hurricanes Katrina, Maria, Harvey and Irma), wildfires (e.g., California wildfires), flooding (e.g., Hurricane Harvey floods in Texas), and public health crises (e.g., Flint, Michigan lead contamination crises). To help Medicaid agencies prepare for such disasters in the future, the Centers for Medicare and Medicaid Services (CMS) Coverage Learning Collaborative developed a set of tools on the strategies available to support Medicaid operations and enrollees in times of crisis. Those tools are: (1) This memorandum which provides a high-level summary of the types of Medicaid and CHIP strategies that can be deployed by states and Territories. It is organized by operational area--eligibility and enrollment, benefits and cost sharing and provider workforce--and provides examples of how the strategies were used by other states and Territories. The memorandum also provides a review of the legal authorities that are available to effectuate various strategies, ranging from changes to State Plan Amendments to obtaining an 1135 Waiver. Finally, Appendix A provides a snapshot summary of the strategies, legal authorities and state examples. (2) A companion inventory of the various strategies available to states and the action needed to effectuate them. Based on interviews with federal officials and a review of federal statute, regulation and approved 1135 and 1115 demonstrations, the CMS Coverage Learning Collaborative team compiled a detailed list of all available strategies, some of which are available without needing approval from CMS. The inventory provides significantly more detail on available options than the memorandum."
Centers for Medicare & Medicaid Services (U.S.)
2018-08-20
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Medicaid and CHIP Coverage Learning Collaborative: Inventory of Medicaid and CHIP Flexibilities and Authorities in the Event of a Disaster
"Medicaid has played a critical role in helping states and Territories respond to public health crises and natural and human-made disasters such as hurricanes (e.g., Hurricanes Katrina, Maria, Harvey and Irma), wildfires (e.g., California wildfires), flooding (e.g., Hurricane Harvey floods in Texas), and public health crises (e.g., Flint, Michigan lead contamination crises). To help Medicaid agencies prepare for such disasters in the future, the Centers for Medicare and Medicaid Services (CMS) Coverage Learning Collaborative developed a set of tools to prepare states on the strategies available to support Medicaid operations and enrollees in times of crisis."
Centers for Medicare & Medicaid Services (U.S.)
2018-08-20
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Role of Medicaid and CHIP in Responding to Public Health Crises and Disasters [presentation]
These presentation slides address the role of Medicaid/CHIP [Children's Health Insurance Program] in responding to emergencies and/or disasters that involve a public health crisis.
Centers for Medicare & Medicaid Services (U.S.)
2018-08-13
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Opening Up America Again: Centers for Medicare & Medicaid Services (CMS) Recommendations: Re-Opening Facilities to Provide Non-Emergent Non-COVID-19 Healthcare: Phase 1
From the Document: "The United States is experiencing an unprecedented public health emergency from the COVID-19 [coronavirus 2019] pandemic. Healthcare facilities in some areas are stretched to their limits of capacity, and surge areas have been needed to augment care for patients with COVID-19. To expand capacity to care for these patients and to conserve adequate staff and supplies, especially personal protective equipment (PPE), on March 18 the Centers for Medicare & Medicaid Services (CMS) recommended limiting non-essential care and expanding surge capacity into ambulatory surgical centers and other areas. However, CMS recognizes that at this time many areas have a low, or relatively low and stable incidence of COVID-19, and that it is important to be flexible and allow facilities to provide care for patients needing non-emergent, non-COVID-19 healthcare. In addition, as states and localities begin to stabilize, it is important to restart care that is currently being postponed, such as certain procedural care (surgeries and procedures), chronic disease care, and, ultimately, preventive care. Patients continue to have ongoing healthcare needs that are currently being deferred. Therefore, if states or regions have passed the Gating Criteria (symptoms, cases, and hospitals) announced on April 16, 2020, then they may proceed to Phase I."
Centers for Medicare & Medicaid Services (U.S.)
2020-04-19
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Center for Clinical Standards and Quality/Quality, Safety & Oversight Group
From the Background: "The Centers for Medicare & Medicaid Services (CMS) is responsible for ensuring the health and safety of nursing home residents by enforcing the standards required to help each resident attain or maintain their highest level of well-being. In light of the recent spread of COVID-19, we are providing additional guidance to nursing homes to help control and prevent the spread of the virus."
Centers for Medicare & Medicaid Services (U.S.)
2020-03-13
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Guidance for Infection Control and Prevention of Coronavirus Disease 2019 (COVID-19) in Nursing Homes
From the Memorandum Summary: "[1] CMS [Centers for Medicare & Medicaid Services] is 'committed' to taking critical steps to ensure America's health care facilities and clinical laboratories are prepared to respond to the threat of the COVID-19 [Coronavirus Disease 2019]. [2] Guidance for Infection Control and Prevention of COVID-19 - CMS is providing additional guidance to nursing homes to help them improve their infection control and prevention practices to prevent the transmission of COVID-19. [3] Coordination with the Centers for Disease Control (CDC) and local public health departments - We encourage all nursing homes to monitor the CDC website for information and resources and contact their local health department when needed (CDC Resources for Health Care Facilities: [https://www.cdc.gov/coronavirus/2019- ncov/healthcare-facilities/index.html])."
Centers for Medicare & Medicaid Services (U.S.)
2020-03-04
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Prioritization of Survey Activities
From the Memorandum Summary: "[1] 'The Centers for Medicare & Medicaid Services (CMS) is committed' to taking critical steps to ensure America's health care facilities are prepared to respond to the threat of disease caused by the 2019 Novel Coronavirus (COVID-19). [2] On Friday, March 13, 2020, the President declared a national emergency, which triggers the Secretary's ability to authorize waivers or modifications of certain requirements pursuant to section 1135 of the Social Security Act (the Act). Under section 1135(b)(5) of the Act, CMS is prioritizing surveys by authorizing modification of timetables and deadlines for the performance of certain required activities, delaying revisit surveys, and generally exercising enforcement discretion for three weeks."
Centers for Medicare & Medicaid Services (U.S.)
2020-03-23
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Guidance for Infection Control and Prevention of Coronavirus Disease 2019 (COVID-19) in Nursing Homes (Revised)
From the Background: "The Centers for Medicare & Medicaid Services (CMS) is responsible for ensuring the health and safety of nursing home residents by enforcing the standards required to help each resident attain or maintain their highest level of well-being. In light of the recent spread of COVID-19, we are providing additional guidance to nursing homes to help control and prevent the spread of the virus."
Centers for Medicare & Medicaid Services (U.S.)
Wright, David
2020-03-13
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Guidance for Infection Control and Prevention Concerning Coronavirus Disease (COVID-19): FAQs and Considerations for Patient Triage, Placement and Hospital Discharge
From the Background: "The Centers for Medicare & Medicaid Services (CMS) is committed to the protection of patients and residents of healthcare facilities from the spread of infectious disease. This memorandum responds to questions we have received and provides important guidance for hospitals and critical access hospitals (CAH's) in addressing the COVID-19 [coronavirus disease 2019] outbreak and minimizing transmission to other individuals. Specifically, we address FAQs [frequently asked questions] related to optimizing patient placement, with the goal of addressing the needs of the individual patient while protecting other patients and healthcare workers."
Centers for Medicare & Medicaid Services (U.S.)
2020-03-04
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General Provider Telehealth and Telemedicine Tool Kit
From the Intent of the Toolkit: "Under President Trump's leadership to respond to the need to limit the spread of community COVID-19 [coronavirus disease 2019], the Centers for Medicare & Medicaid Services (CMS) has broadened access to Medicare telehealth services so that beneficiaries can receive a wider range of services from their doctors without having to travel to a healthcare facility. These policy changes build on the regulatory flexibilities granted under the President's emergency declaration. CMS is expanding this benefit on a temporary and emergency basis under the 1135 waiver authority and Coronavirus Preparedness and Response Supplemental Appropriations Act. The benefits are part of the broader effort by CMS and the White House Task Force to ensure that all Americans - particularly those at high-risk of complications from the virus that causes the disease COVID-19, are aware of easy-to-use, accessible benefits that can help keep them healthy while helping to contain the community spread of this virus."
Centers for Medicare & Medicaid Services (U.S.)
2020?
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Guidance for Infection Control and Prevention Concerning Coronavirus Disease 2019 (COVID-19) in Home Health Agencies (HHAs)
From the Background: "The Centers for Medicare & Medicaid Services (CMS) is committed to the protection of patients in the home care setting from the spread of infectious disease. This memorandum responds to questions we have received and provides important guidance for all Medicare and Medicaid participating Home Health Agencies (HHAs) in addressing the COVID-19 [coronavirus disease 2019] outbreak and minimizing transmission to other individuals."
Centers for Medicare & Medicaid Services (U.S.)
2020-03-10
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Long-Term Care Nursing Homes Telehealth and Telemedicine Tool Kit
From the Intent: "Under President Trump's leadership to respond to the need to limit the spread of community COVID-19 [coronavirus disease 2019], the Centers for Medicare & Medicaid Services (CMS) has broadened access to Medicare telehealth services so that beneficiaries can receive a wider range of services from their doctors without having to travel to a healthcare facility. These policy changes build on the regulatory flexibilities granted under the President's emergency declaration. CMS is expanding this benefit on a temporary and emergency basis under the 1135 waiver authority and Coronavirus Preparedness and Response Supplemental Appropriations Act. The benefits are part of the broader effort by CMS and the White House Task Force to ensure that all Americans - particularly those at high-risk of complications from the virus that causes the disease COVID-19, are aware of easy-to-use, accessible benefits that can help keep them healthy while helping to contain the community spread of this virus."
Centers for Medicare & Medicaid Services (U.S.)
2020-03-27
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COVID-19 Emergency Declaration Blanket Waivers for Health Care Providers
From the Document: "The Trump Administration is taking aggressive actions and exercising regulatory flexibilities to help healthcare providers contain the spread of 2019 Novel Coronavirus Disease (COVID-19). CMS [Centers for Medicare & Medicaid Services] is empowered to take proactive steps through 1135 waivers as well as, where applicable, authority granted under section 1812(f) of the Social Security Act (the Act) and rapidly expand the Administration's aggressive efforts against COVID-19. As a result, the following blanket waivers are in effect, with a retroactive effective date of March 1, 2020 through the end of the emergency declaration."
Centers for Medicare & Medicaid Services (U.S.)
2020-04-29
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COVID-19 Emergency Declaration Health Care Providers Fact Sheet
From the Document: "The Trump Administration is taking aggressive actions and exercising regulatory flexibilities to help healthcare providers combat and contain the spread of 2019 Novel Coronavirus Disease (COVID-19). In response to COVID-19, CMS [Centers for Medicare & Medicaid Services] is empowered to take proactive steps through 1135 waivers and rapidly expand the Administration's aggressive efforts against COVID-19. As a result, the following blanket waivers are available."
Centers for Medicare & Medicaid Services (U.S.)
2020-03-13
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Information for PACE Organizations Regarding Infection Control and Prevention of Coronavirus Disease 2019 (COVID-19)
From the Document: "The Centers for Medicare & Medicaid Services is committed to the protection of individuals from the spread of infectious disease. In light of the recent spread of COVID-19, we are providing information to PACE [Program of All-inclusive Care for the Elderly] Organizations (POs) to help control and prevent the spread of the virus that causes COVID-19. [...] Per current CDC [Centers for Disease Control and Prevention] guidelines, health care providers should put into practice strategies for preventing the spread of COVID-19, such as reviewing infection control practices with all personnel, implementing proper hand and respiratory hygiene; monitoring participants, personnel, and visitors for fever and respiratory symptoms; using alcohol-based hand sanitizers; and keeping all individuals including visitors, staff, and residents at home when they are ill. POs should implement sick leave policies for personnel that are non-punitive, flexible, and consistent with public health guidance."
Centers for Medicare & Medicaid Services (U.S.)
2020-03-17
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COVID-19 Frequently Asked Questions (FAQs) for State Medicaid and Children's Health Insurance Program (CHIP) Agencies
This document from the Centers for Medicare & Medicaid Services provides answers to frequently asked questions regarding how to deal with the coronavirus disease 2019 (COVID-19) outbreak.
Centers for Medicare & Medicaid Services (U.S.)
2020-03-18
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Upcoming Requirements for Notification of Confirmed COVID-19 (Or COVID-19 Persons Under Investigation) Among Residents and Staff in Nursing Homes
From the Document: "The Centers for Medicare & Medicaid Services (CMS) is responsible for ensuring the health and safety of nursing home residents by enforcing the standards required to help each resident attain or maintain their highest level of well-being. In light of the recent spread of COVID-19 [coronavirus disease 2019], we are providing additional direction to nursing homes to help control and prevent the spread of the disease. [...] Nursing homes are currently required to establish and maintain an infection prevention and control program designed to provide a safe, sanitary, and comfortable environment and to help prevent the development and transmission of communicable diseases and infections. This includes a system of surveillance designed to identify possible communicable diseases or infections before they can spread to other persons in the facility. Further, nursing homes are required to know when and to whom possible incidents of communicable disease or infections should be reported."
Centers for Medicare & Medicaid Services (U.S.)
2020-04-19
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Toolkit on State Actions to Mitigate COVID-19 Prevalence in Nursing Homes
From the Objective: "This toolkit catalogs the many innovative solutions designed at the state level to protect our nation's vulnerable nursing home residents during the Coronavirus disease 2019 (COVID-19) pandemic."
Centers for Medicare & Medicaid Services (U.S.)
2020-05
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Nursing Home Reopening Recommendations for State and Local Officials
From the Document: "This memorandum provides recommendations for State and local officials to help them determine the level of mitigation needed for their communities' Medicare/Medicaid certified long term care facilities (hereinafter, 'nursing homes') to prevent the transmission of COVID-19 [coronavirus disease 2019]. We encourage State leaders to collaborate with the state survey agency, and State and local health departments to decide how these and other criteria or actions should be implemented in their state."
Centers for Medicare & Medicaid Services (U.S.)
2020-05-18
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COVID-19 Survey Activities, CARES Act Funding, Enhanced Enforcement for Infection Control Deficiencies, and Quality Improvement Activities in Nursing Homes
From the Background: "The coronavirus presents a unique challenge for nursing homes. Therefore, CMS [Centers for Medicare & Medicaid Services] is using every tool at our disposal to protect our nation's most vulnerable citizens and aid the facilities that care for them. Since the pandemic began, CMS, in coordination with the Centers for Disease Control and Prevention (CDC), has provided ongoing technical guidance and assistance to all Medicare and Medicaid certified providers and suppliers, including nursing homes. Nursing homes have been ground zero for COVID-19 [coronavirus disease 2019]. As the data from our required COVID-19 reporting from nursing homes indicates, additional immediate action is necessary to safeguard the health and safety of residents."
Centers for Medicare & Medicaid Services (U.S.)
2020-06-01
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Frequently Asked Questions: COVID-19 Testing at Skilled Nursing Facilities/ Nursing Homes
From the Document: "Nursing homes will receive either a Quidel Sofia 2 Instrument or Becton, Dickinson and Company (BD) Veritor™ Plus System over the coming months along with the associated FDA-authorized antigen diagnostic tests. To be eligible, nursing homes must have a current CLIA [Clinical Laboratory Improvement Amendments] Certificate of Waiver AND meet certain epidemiological criteria. The list of nursing homes is posted on the Centers for Medicare & Medicaid Services (CMS) COVID [coronavirus disease] NHSN [National Healthcare Safety Network] data page and will be updated as new shipments go out. The U.S. Department of Health and Human Services (HHS) will distribute the testing platforms and FDA-authorized antigen diagnostic tests to all nursing homes with a CLIA Certificate of Waiver over the next few months. Nursing homes mean facilities that are certified as a Medicare Skilled Nursing Facility (SNF) and/or Medicaid Nursing Facility (NF), otherwise referred to a Long Term Care Facility or nursing home."
Centers for Medicare & Medicaid Services (U.S.)
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COVID-19 Nursing Home Data [website]
From the Website: "The Nursing Home COVID-19 [coronavirus disease 2019] Public File includes data reported by nursing homes to the CDC's National Healthcare Safety Network (NHSN) system COVID-19 Long Term Care Facility Module, including Resident Impact, Facility Capacity, Staff & Personnel, and Supplies & Personal Protective Equipment, and Ventilator Capacity and Supplies Data Elements."
Centers for Medicare & Medicaid Services (U.S.)
2020
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Toolkit on State Actions to Mitigate COVID-19 Prevalence in Nursing Homes [September 2020, Version 9]
From the Objective: "This toolkit catalogs the many innovative solutions designed at the state level to protect our nation's vulnerable nursing home residents during the Coronavirus disease 2019 (COVID-19) pandemic."
Centers for Medicare & Medicaid Services (U.S.)
2020-09
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Enforcement Cases Held During the Prioritization Period and Revised Survey Prioritization
From the Background: "On Friday, March 13, 2020, the President declared a national emergency due to the COVID-19 [coronavirus disease 2019] public health emergency (PHE), which triggered the Secretary's ability to authorize waivers or modifications of certain requirements pursuant to section 1135 of the Social Security Act (the Act). Under section 1135(b)(5) of the Act, CMS prioritized surveys by authorizing modification of timetables and deadlines for the performance of certain required activities. [...] In addition, COVID-19 presents a unique challenge for clinical laboratories with the rapid expansion of COVID-19 testing. To allow for the rapid expansion of testing, CMS worked collaboratively with the U.S. Food and Drug Administration (FDA) and U.S. Centers for Disease Control and Prevention (CDC) to provide ongoing technical guidance and assistance regarding COVID-19 testing, and processing of Clinical Laboratory Improvement Amendments (CLIA) certificate applications during the public health emergency to the laboratory community and State agencies."
Centers for Medicare & Medicaid Services (U.S.)
2020-08-17
