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.

Essential resources for health care providers & attorneys during hurricane season

Hurricane season has arrived and health care providers in affected areas are focusing on providing services to injured individuals and rebuilding damage to facilities, but not necessarily on compliance with Medicare and Medicaid laws and regulations. To assist providers, federal and state agencies are temporarily waiving some regulatory requirements and providing other emergency services. While active hurricane recovery efforts are underway, Health Law Daily will feature links to federal and state resources.

Federal information:

State- and commonwealth-specific information:

HHS Sec. Price: Trump’s FY 2018 budget does not ‘confuse spending with success’

On May 23, 2017, President Trump submitted his fiscal year (FY) 2018 budget proposal to Congress. The proposed budget contained the administration’s tax, spending, and policy proposals for FY 2018. The proposed budget was greeted with much criticism due to various program cuts (see $3.6T in cuts spells R-E-S-P-E-C-T in Trump budget, Health Law Daily, May 23, 2017). On June 8, 2017, HHS Secretary Price appeared before the House Ways & Means Committee and discussed the President’s proposals involving HHS programs.

Confusing spending with success

Because the President’s FY 2018 budget was met with so much criticism due to various program cuts, Price began by taking on that issue directly: “President Trump’s budget request does not confuse government spending with government success. The President understands that setting a budget is about more than establishing topline spending levels. Done properly, the budgeting process is an exercise in reforming our federal programs to make sure they actually work—so they do their job and use tax dollars wisely.”

Price continued: “The problem with many of our federal programs is not that they are too expensive or too underfunded. The real problem is that they do not work—they fail the very people they are meant to help. Fixing a broken government program requires a commitment to reform — redesigning its basic structure and refocusing taxpayer resources on innovative means to serve the people that the program is supposed to serve. And sometimes it requires recognition that the program is unnecessary because the need no longer exists or there are other programs that can better meet the needs of the people that the program was originally designed to serve.”

To emphasize this point, Price spoke directly about two federal programs, Aid to Families with Dependent Children and Medicaid.

Aid to Families with Dependent Children

According to Price, the Aid to Families with Dependent Children program undermined self-sufficiency and work. He applauded Congressional action that created the Temporary Assistance for Needy Families (TANF) program that promoted the empowerment of parents through work. He pointed out that TANF caseloads have declined by 75 percent through FY 2016. And that under the TANF program, the employment of single mothers increased by 12 percent from 1996 through 2000, and even after the 2008 recession, employment of single mothers is still higher than before welfare reform.


With regards to the Medicaid program, Price stressed that 20 years ago, annual government spending on Medicaid was less than $200 billion; and that within the next decade, that figure is estimated to top $1 trillion. Despite these investments, Price noted that: (1) one-third of doctors in America do not accept new Medicaid patients; and (2) research shows that enrolling in Medicaid does not necessarily lead to healthier outcomes for the newly eligible enrollee.

To illustrate the failure to achieve healthier outcomes, Price pointed to the results of an Oregon Health Insurance Study that replicated a randomized clinical trial by enrolling some uninsured people in Medicaid through a lottery. Comparing this population to those who remained without coverage, the data showed an increase in emergency room use for primary care, the probability of a diagnosis of diabetes, and the use of diabetes medication. The data also showed no significant effects on measures of physical health such as blood pressure, cholesterol, or average glycated hemoglobin levels (a diagnostic criterion for diabetes).

According to Price, “This mixed impact of Medicaid coverage on health outcomes suggests we need structural reforms that equip states with the resources and flexibility they need to serve their unique Medicaid populations in a way that is as compassionate and as cost-effective as possible.” This is what the President’s FY 2018 budget does, according to Price. It uses state innovation to save and strengthen Medicaid by unleashing state-level policymakers to advance reforms that are tailor-made to meet the unique needs of their citizens. Price estimates that over the next decade, these reforms will save American taxpayers $610 billion.


Price further testified that the FY 2018 budget includes provisions to extend funding for the Children’s Health Insurance Program (CHIP). The budget would rebalance the federal-state partnership through a series of reforms, including ending the requirement under section 2001 of the Patient Protection and Affordable Care Act (ACA) (P.L. 111-148) that states move certain children from CHIP into Medicaid and capping eligibility at 250 percent of the federal poverty level to return the focus of CHIP to the most vulnerable and low-income children.

Health security and preparedness

Price affirmed HHS’ role as “the world’s leader in responding to and protecting against public health emergencies — from outbreaks of infectious disease to chemical, biological, radiological, and nuclear threats — and assisting the health care sector to be prepared for cyber threats.”

To support HHS’ public health emergency preparedness and response, Price noted that the President’s budget provides $4.3 billion for disaster services coordination and response planning, biodefense and emerging infectious diseases research, and development and stockpiling of critical medical countermeasures.

Key Public Health Priorities

In his testimony, Price described three new public health crises: (1) serious mental illness; (2) substance abuse, particularly the opioid abuse epidemic; and (3) childhood obesity. He stressed his commitment to these new challenges and noted that the President’s budget would:

  • invest $5 million in new funding authorized by the 21st Century Cures Act for Assertive Community Treatment for Individuals with Serious Mental Illness;
  • include a demonstration within the Children’s Mental Health Services program to test the applicability of new research from the National Institute of Mental Health on preventing or delaying the first episode of psychosis;
  • provide $811 million — an increase of $50 million above the FY 2017 continuing resolution — in support of HHS’ five-part strategy to combat the opioid epidemic; and
  • establish a new $500 million America’s HealthBlock Grant, which will provide flexibility for states and Tribes to implement specific interventions, including those designed to spur improvements in physical activity and the nutrition of children and adolescents, and to treat leading causes of death such as heart disease.

Women’s health services

Price also testified that the President’s budget would increase funding for the Maternal and Child Health Block Grant and Healthy Start to improve the health of mothers, children, and adolescents, particularly those in low-income families. The budget would also maintain funding for a variety of programs serving women, including, community health centers, domestic violence programs, women’s cancer screenings and support, mother and infant programs, and the Office on Women’s Health.

Highlight on Florida: Hurricane causes hospital closures, requires extra support for vulnerable patients

Florida health care facilities were forced to make serious operating choices when Hurricane Matthew hit, and provided recommendations to the public that may be important during future emergency situations. In such situations, hospitals strive to allocate staffing and provisions to best meet patients’ needs, and rely on locals to seek shelter elsewhere.

Hospital closures, evacuations

The state of Florida faced some serious health care delivery concerns when Hurricane Matthew hit last week. Jackson Health System, a major hospital system in Miami, planned to operate as normally as possible, except for some clinics that closed Thursday and Friday. Broward Health, a five-hospital system, took the opposite approach and closed all hospitals except for emergencies and trauma patients. All outpatient procedures were canceled on Thursday and Friday. Baptist Health kept hospitals and emergency rooms open, but closed some of its centers. Cape Canaveral Hospital, Baptist Medical Center Beaches, and three Florida Hospital locations were forced to evacuate patients. Although Florida Hospital Flager remained opened for emergencies, Ormond Beach and New Smyrna Beach locations closed their ERs.

Storm considerations

Hospitals offered some advice for locals, and urged patients not to plan on using hospitals as a last-minute shelter option. One official said that every year, some individuals show up seeking to wait out the hurricane at the hospital, requiring staff to be diverted away from patient care. According to the Orlando Sentinel, counties established shelters for those with special needs that are staffed with nurses and have some equipment. Hospitals also warned that patients needing medications would not be able to pick them up at a hospital and would be forced to proceed through the ER to get prescriptions.

Jackson Health posted a special advisory for women planning to deliver their baby at one of its facilities, outlining who should report to the hospital when a hurricane warning takes effect. Women carrying multiple babies who are at least 34 weeks along, having a history of preterm labor, or have placental implantation issues at least 28 weeks into their pregnancy were encouraged to come to the hospital and be prepared for admission. Others were told to call their physician and report to the hospital if referred.

Other patients, such as those requiring oxygen and dialysis, were also particularly vulnerable in this situation. Over 500,000 such patients were in the hurricane’s path. Chen Senior Medical Centers identified many vulnerable patients and called them individually, asking about their conditions and needs. Oxygen was provided at no cost to those who needed it. There was also a federal Disaster Distress Helpline staffed to provide immediate crisis counseling.