Emergency Preparedness

Subscribe to Emergency Preparedness

Following the distribution of billions of relief aid to healthcare providers and amidst the guidance issued around reopening of nursing homes throughout the country, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) unveiled a COVID-19 Response Strategic Plan on May 26, 2020 after updating its Workplan a few days earlier.…

The recently passed “Coronavirus Aid, Relief, and Economic Security Act” (CARES Act) is sweeping legislation that will have widespread impact on companies in the health care and life sciences space. In addition to expanding coverage of COVID-19 testing and preventive services, the Act includes provisions to address health care workforce needs, eases restrictions surrounding telehealth…

In a recent guidance, the Centers for Medicare & Medicaid Services (CMS) encouraged health care providers (HCPs) to limit elective surgeries and nonessential procedures during the 2019 novel coronavirus (COVID-19) outbreak.

CMS offered a number of recommendations to help HCPs decide how to best serve patients requiring emergent or urgent attention. In addition to clinical…

The Centers for Medicare & Medicaid Services (CMS) has issued an “omnibus burden reduction” rule that finalizes a September 20, 2018 proposed rule intended to streamline various Medicare and Medicaid regulatory requirements, in alignment with the Administration’s “Patients over Paperwork” initiative.  The omnibus regulation also finalizes a November 4, 2016 proposed rule on…

CMS has issued a proposed rule intended streamline the Medicare and Medicaid regulatory burden on numerous types of providers and suppliers.  CMS generally classifies the proposals as falling into the following categories:  (1) those that simplify and streamline processes, (2) those that reduce the frequency of activities and revise timelines, and (3) those that address…

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 …

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,…

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, and dynamic regulatory approach to emergency preparedness and response that incorporates the lessons learned from the past, combined with the proven best practices of the present.”  CMS projects that compliance with the rule will cost $373 million in the first year, with subsequent annual costs of approximately $25 million.

The new requirements apply to 17 provider types (with certain variations): hospitals; critical access hospitals (CAHs); long-term care (LTC) facilities; psychiatric residential treatment facilities; intermediate care facilities for individuals with intellectual disabilities; religious nonmedical health care institutions; transplant centers; hospices; ambulatory surgical centers; Program for the All-inclusive Care for the Elderly (PACE) organizations; home health agencies; comprehensive outpatient rehabilitation facilities; community mental health centers; organ procurement organizations; clinics, rehabilitation, and therapy providers; rural health clinics/federally qualified health clinics; and end-stage renal disease providers.

The sweeping final rule (the advance version spans 651 pages) covers four aspects of emergency preparedness:
Continue Reading CMS Finalizes Emergency Preparedness Requirements for Medicare/Medicaid Providers

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…

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 “covered entities,” like Orlando Regional Medical Center, are permitted to disclose without proper patient authorization or consent.

Shortly following the massacre, Orlando local news outlets reported that after Orlando Regional’s CEO expressed concern regarding families requesting detailed patient health information at the hospital’s emergency room, Orlando Mayor Buddy Dyer contacted the White House and requested a waiver of the HIPAA regulations.  While the HIPAA Privacy Rule is not automatically suspended during a national or public health emergency, the Secretary of the Department of Health and Human Services (HHS) may waive certain provisions of HIPAA under the Project Bioshield Act of 2004 (PL 108-276) and section 1135(b)(7) of the Social Security Act.  In order to take advantage of the waiver, the President must declare an emergency or disaster and the Secretary of HHS must declare a public health emergency.Continue Reading Reexamining HIPAA’s Applicability During Emergencies After the Tragedy in Orlando

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

…

Three health policy hearings are scheduled for February 26, 2015:

…

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

…

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…

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…

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…

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…