Tag Archives: Emergency Preparedness

CMS Encourages Providers/Suppliers Not To Put Off Emergency Preparedness Training Exercises; Educational Call Scheduled for April 27

CMS is reminding Medicare- and Medicaid-participating providers and suppliers that they will be expected to comply with training and testing requirements included in a September 2016 emergency preparedness final rule by November 15, 2017.  In particular, CMS warns providers and suppliers not to wait for interpretive guidance to begin planning emergency exercises, since those who … Continue Reading

CMS Call on New Medicare/Medicaid Emergency Preparedness Requirements (Oct. 5)

On October 5, 2016, CMS is hosting a call to discuss its September 16, 2016 final rule establishing emergency preparedness requirements for Medicare- and Medicaid-participating providers and suppliers to ensure that they can meet the needs of patients and residents during natural and man-made emergency situations. The call will discuss provisions of the final rule, … Continue Reading

CMS Finalizes Emergency Preparedness Requirements for Medicare/Medicaid Providers

The Centers for Medicare & Medicaid Services (CMS) has released a long-awaited final rule establishing emergency preparedness requirements for Medicare- and Medicaid-participating providers and suppliers to ensure that they can meet the needs of patients and residents during emergency situations, both natural and man-made. According to CMS, the final requirements “establish a comprehensive, consistent, flexible, … Continue Reading

Committees Approve Rural Hospital Relief, ESRD Benefits, Medical Countermeasures Bills

On July 13, 2016, the Ways and Means Committee approved HR 5659, which would enable Medicare beneficiaries with end stage renal disease (ESRD) to enroll in Medicare Advantage plans. Earlier this month, the Committee approved HR 5613, to prevent CMS from enforcing a Medicare requirement for direct physician supervision of certain outpatient therapeutic services furnished … Continue Reading

Reexamining HIPAA’s Applicability During Emergencies After the Tragedy in Orlando

Immediately following Sunday’s tragic shooting at a nightclub in Orlando, friends and family frantically gathered at Orlando Regional Medical Center, attempting to get information about their loved ones.  However, hospital officials hesitated to provide specific updates.  Why?  Because the Health Insurance Portability and Accountability Act (HIPAA) and implementing regulations restrict the patient-identifiable health information that … Continue Reading

OIG Issues 2015 Compendium of Unimplemented Recommendations

The OIG has released its March 2015 “Compendium of Unimplemented Recommendations,” which highlights the OIG’s top 25 recommendations for cost savings and/or quality improvements in HHS programs, along with other significant unimplemented recommendations. High-priority recommendations address the following areas, among others: Payment Policies and Practices: Expand the DRG window to include additional days prior to the inpatient … Continue Reading

Congressional Hearings to Focus on HHS Budget, Medical Preparedness, ACA Implementation

Three health policy hearings are scheduled for February 26, 2015: The Energy and Commerce Committee is holding a hearing on the Obama Administration’s proposed FY 2016 budget for the Department of Health and Human Services (HHS); The Senate HELP Committee is holding a hearing entitled “Medical and Public Health Preparedness and Response: Are We Ready … Continue Reading

CMS Proposes Emergency Preparedness Requirements for Medicare/Medicaid Providers

On December 27, 2013, CMS published a proposed rule that would establish national emergency preparedness requirements for Medicare- and Medicaid-participating providers and suppliers to ensure that they can meet the needs of patients and residents during emergency situations, both natural and man-made. The proposed requirements cover four aspects of emergency preparedness: Risk assessment and planning: Providers and … Continue Reading

Congress Clears Pandemic and All-Hazards Preparedness Reauthorization Act

On March 4, 2013, the House gave final approval to H.R. 307, the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013, after approving amendments adopted by the Senate on February 27, 2013. The legislation reauthorizes programs intended to strengthen the nation’s preparedness infrastructure and support development of medical countermeasures to respond to chemical, biological, radiological, … Continue Reading

House Passes Pandemic and All-Hazards Preparedness Reauthorization Act

On January 22, 2013, the House of Representatives approved H.R. 307, the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013, by a bipartisan vote of 395 to 29. The legislation would reauthorize programs intended to strengthen the nation’s preparedness infrastructure and support development of medical countermeasures to respond to chemical, biological, radiological, and nuclear attacks. … Continue Reading

OIG Examines Nursing Home Emergency Preparedness

The OIG has issued a report entitled “Gaps Continue To Exist in Nursing Home Emergency Preparedness and Response during Disasters: 2007–2010.” According to the OIG, most nursing homes nationwide met federal requirements for written emergency plans and preparedness training. Some gaps in nursing home preparedness and response continue, however, including unreliable transportation contracts, lack of … Continue Reading

Final Rule Regarding Labeling Requirements for Products Held in Strategic National Stockpile

This post was written by Erin A. Janssen. On February 6, 2012, the FDA adopted as a final rule, without change, the interim final rule from December 28, 2007 that permitted FDA Center Directors to grant exceptions or alternatives to certain regulatory labeling requirements applicable to human drugs, biological products, or medical devices that are … Continue Reading

Congressional Panels Consider Generic Drug Promotion, Other Health Policy Legislation

On July 21, 2011, the Senate Judiciary Committee approved S. 27, the Preserve Access to Affordable Generics Act, which would prohibit certain so-called “pay-for-delay” agreements in patent litigation settlements in which a brand-name pharmaceutical company compensates a generic pharmaceutical company for delays in generic entry. On July 28, 2011, the House Energy and Commerce Committee approved … Continue Reading

Congressional Hearings on ACA, Medicare & Other Health Policies

Several Congressional committees have held hearings on various aspects of the ACA, including: A House Oversight Health Care Subcommittee hearing on “Obamacare: Why The Need For Waivers?”; a Senate Finance Committee hearing on “Health Reform: Lessons Learned During the First Year“; a Senate Health, Education, Labor and Pensions Committee hearing examining “Health Insurance Exchanges and Ongoing State Implementation … Continue Reading

Countermeasures Injury Compensation Program (CICP) Interim Final Rule Published

On October 15, 2010, the Health Resources and Services Administration (HRSA) published an interim final rule with request for comments establishing the administrative policies and procedures for the CICP, as authorized by the Public Readiness and Emergency Preparedness Act (PREP Act). The CICP provides benefits to certain persons who sustain serious physical injuries or death … Continue Reading

HHS Report on Medical Countermeasures Strategy

On August 19, 2010, HHS released a report entitled “The Public Health Emergency Medical Countermeasure Enterprise Review: Transforming the Enterprise to Meet Long Range National Needs.” Prepared in response to the H1N1 pandemic flu experience, the HHS report reviews the federal government’s role in producing medical countermeasures — medications, vaccines, equipment and supplies for a … Continue Reading

FDA Guidance Document: Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products

This post was written by Paul Sheives. The FDA has issued a guidance document seeking to encourage the creation of contingency production plans for the manufacture of medically-necessary drug products and their components during emergencies that result in high absenteeism at production facilities. Medically-necessary products are those used to treat or prevent a serious disease or … Continue Reading

HHS Releases National Health Security Strategy

On January 7, 2010, HHS released the National Health Security Strategy, which sets priorities for government and private activities designed to protect the population’s health during a large-scale emergency, such as bioterrorism, pandemics, and natural disasters. The strategy and accompanying interim implementation guide outline 10 objectives to achieve health security, including goals in such areas … Continue Reading

Pandemic Flu: Legal Issues for Health Providers

CMS is encouraging hospitals and other health care providers to review a new publication, “Community Pan-Flu Preparedness: A Checklist of Key Legal Issues for Healthcare Providers," which is the result of a public interest dialogue session convened by the American Health Lawyers Association, the HHS Office of Inspector General, and the U.S. Centers for Disease … Continue Reading

Emergency Assistance in Hurricane Areas

HHS Secretary Michael Leavitt has declared that a public health emergency exists in Louisiana, Texas, Mississippi, and Alabama as a result of Hurricane Gustav. The declaration triggers waivers of certain Medicare, Medicaid, and SCHIP rules in the affected states. In a related development, on September 3, 2008 HHS announced implementation of the “Disaster Case Management” demonstration program … Continue Reading

Emergency Preparedness Grants, Draft Guidance Developments

On June 3, 2008, HHS announced that it has made available nearly $1.1 billion to continue assisting public health departments, hospitals and other health care organizations respond to public health and medical emergencies resulting from terrorism, pandemic influenza, and other naturally occurring emergencies. In a related development, HHS has released three draft guidance documents. designed to … Continue Reading

Public Health Emergency Medical Countermeasures Enterprise Meeting

HHS is holding a Public Health Emergency Medical Countermeasures Enterprise Stakeholders Workshop on September 24–26, 2008. This event will provide an open forum for the pharmaceutical and biotechnology industry, first responders, policymakers, public health advocates, and others to discuss the development, acquisition, and distribution of medical countermeasures against chemical, biological, radiological, nuclear, and naturally emerging threats. … Continue Reading
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