CMS, FDA provide support in response to natural disasters

In response to the natural disasters that have inundated the U.S. in recent months, CMS and the FDA have provided additional support to the individuals and businesses dealing with the aftermath.


Administrator Seema Verma announced on October 19, 2017, support for California residents displaced and recovering from the October wildfires in response to the declaration of a public health emergency for the state by Acting HHS Secretary Eric D. Hargan. Such a declaration permits CMS to waive or modify certain Medicare, Medicaid, and Children’s Health Insurance Program (CHIP) requirements to provide necessary services. Specifically, the following steps have been taken by CMS:

·         A blanket skilled nursing facility waiver and assistance for hospitals and other health care facilities.

·         Special enrollment period for all Medicare beneficiaries so they may change their health or prescription drug plans immediately.

·         Assistance for dialysis patients displaced from their usual facility.

·         Hotline to assist Part B providers and suppliers in helping recovery efforts and receiving temporary Medicare billing privileges.

Similar assistance was provided in response in areas affected by Hurricanes Harvey, Irma, and Maria (see Emergency preparedness in the wake of historic hurricanes, Health Law Daily, October 3, 2017).



The FDA, knowing that tobacco manufacturers and importers in some areas (including certain Caribbean Islands and counties in Florida, Texas, and California) have been affected by both the hurricanes and wildfires, is extending the compliance deadlines for ingredient listing and health document submission requirements by six months. The extension applies to areas for which a disaster area has been declared by the Federal Emergency Management Agency (FEMA). For non-small-scale manufacturers and importers in the specified areas, the deadline for ingredient listings is now May 8, 2018; for small-scale manufacturers, November 8, 2018. For small-scale manufacturers, the health documents are due May 8, 2018; the non-small-scale manufacturers and importers deadline remains the same—February 8, 2017.

CMS steps up emergency preparedness under Final rule

CMS is requiring Medicare and Medicaid providers to take additional steps to plan for disasters and emergency situations under a new Final rule. In addition to requiring providers to develop their own plans for emergency scenarios, the Final rule obligates Medicare and Medicaid providers to prepare for emergencies by coordinating with federal, state tribal, regional, and local emergency preparedness systems. The rule also imposes training requirements on providers. The Final rule, issued as an advanced release, is set to be published in the Federal Register on September 16, 2016.

Best practices

Under current rules, providers are required to have some emergency preparedness. For example, hospitals must provide for emergency power and lighting in specified areas and provide facilities for emergency gas and water supply. However, CMS believes the current requirements fall short. The Final rule seeks to improve on the status quo by centering requirements on what CMS calls “common and well-known industry best practice standards” for emergency preparedness, including the development of: (1) risk assessment based emergency plans; (2) policies and procedures based upon the risk assessment; (3) a coordinated communication plan to reach within facilities, across providers, and to State and local public health departments and emergency systems; and (4) and a training and testing program including drills and exercises.

Provider-specific requirements

Although all providers are obligated to comply with the Final rule’s best practices, specific requirements vary for individual provider types. For example, outpatient providers, ambulatory surgical centers, and end-stage renal disease facilities are not obligated to develop policies and procedures for provision of subsistence needs. For other providers, there are additional requirements. For example, under their emergency plans, hospitals, critical access hospitals, and long term care facilities must install emergency and standby power systems. Health care providers and suppliers impacted by the rule have one year from the effective date—60 days after publication—to comply with the new regulations.