How Climate Change Might Affect Your Health

On March 16, 2017, President Trump released a preliminary 2018 budget proposal, which outlines some of the changes that the President would like to see. Among those changes, President Trump has proposed a 29% cut to the State Department, which includes the elimination of climate-change prevention programs, including pledged payments to U.N. climate-change programs. The budget also suggested a 31% cut to the Environmental Protection Agency (EPA), which would include the elimination of more than 50 programs and 3,200 jobs and would discontinue funding for international climate-change programs.

Just one day before the budget proposal was released, a group of family physicians, pediatricians, obstetricians, allergists, internists and other medical experts launched the Medical Society Consortium on Climate and Health. More than half of all U.S. doctors are members of one of the participating groups, which include the American College of Physicians (ACP); American Academy of Allergy, Asthma, Immunology (AAAAI); the American Academy of Family Physicians (AAFP); the American Academy of Pediatrics (AAP); and the American Congress of Obstetricians and Gynecologists (ACOG), among others. The mission of the Consortium is to “inform the public and policymakers about the harmful health effects of climate change on Americans, as well as about the immediate and long-term health benefits associated with decreasing greenhouse gas emissions (i.e., heat-trapping pollution) and other preventive and protective measures.”

They presented a new report, “Medical Alert! Climate Change is Harming Our Health,” which includes scientific evidence and accounts from doctors who believe that climate change is creating or worsening a wide range of health issues, including: heart and lung diseases; heat-related health dangers; the spread of infectious disease; and physical and mental health problems. The Consortium is working to raise awareness of the health risks that climate change poses to Americans, especially vulnerable communities who experience a disproportionate impact from climate change. In addition to raising awareness of the impact of climate change on human health, these medical societies are educating and working with policymakers and industry to reduce emissions, promote effective interventions, and strengthen public health infrastructure.

Given the proposed budget changes, EPA Administrator Scott Pruitt’s history of rejection of established science of climate change, and President Trump’s view on climate change, it is unclear what the U.S’ involvement in fighting global warming will look like. In 2016, the U.S signed the Paris Agreement, building upon the United Nations Framework Convention on Climate Change, to fight climate change and to support developing countries in this endeavor.  However, it has yet to be seen whether we will honor our commitment, but if we do not, we possibly risk devastating changes to our environment and also to human health.

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Change or No Change in Healthcare Fraud and Abuse Enforcement?

Practitioners are wondering whether the robust role of the federal government in healthcare fraud and abuse cases will remain the same. In Fiscal Year (FY) 2016, the federal government recovered over $3.3 billion as a result of health care fraud judgments, settlements and additional imposition in health care fraud cases and proceedings. Additionally, in June 2016, the Medicare Fraud Strike Force engaged in a nationwide healthcare fraud takedown that resulted in charges against about 300 individuals that include doctors, nurses and other licensed medical professionals. Rooting out fraud and abuse in healthcare has been a goal of every administration since President Ronald Reagan.

On October 27, 1986, President Reagan signed the False Claims Amendments Act of 1986, which soon became a successful anti-fraud law to deter and fight waste, fraud and abuse in the healthcare field. What makes the False Claims Act (FCA) an important tool to fight any malfeasance in the healthcare system is the qui tam provision that allows whistleblowers to expose fraud against federal government. In 2010, the Patient Protection and Affordable Care Act (ACA) amended portion of the FCA and some of those changes are considered by practitioners to have increased the number of healthcare-related FCA cases. It is undisputed that the FCA allows government to recover billions of dollars, however, the FCA defense bar is awaiting to see if there would be any change to the FCA related provision in ACA. During the confirmation hearing of Attorney General Jeff Sessions, when Senator Charles Grassley asked him to elaborate his intent regarding the FCA, Attorney General Sessions stated, “in the qui tam provisions and the part of that, I’m aware of those. I think they are valid and an effective method of rooting out fraud and abuse. I even filed one myself one time as a private lawyer….” At this point this testimony only serves as a mere reverence for FCA, which is not necessarily a clear indication what will be the effect of qui tam healthcare lawsuits or overall healthcare fraud and abuse enforcement during the Trump Administration.

There are two early signs that are leaning towards the continuity of a vigorous fraud and abuse enforcement. First, the budget that has been released by the Trump White House requested additional $70 million to fund for the Healthcare Fraud and Abuse Control program.  Trump’s proposed budget plan envisioned a whopping budget cut for the Department of Health and Human Service, but the additional request of fund for fraud prevention is likely an early sign of continuity of the robust fraud and abuse enforcement. Second, recently the Department of Justice has joined a whistleblower lawsuit, United States of America ex rel Benjamin Poehling v. Unitedhealth Group Inc., No. 16-08697 (Cent. Dist. Cal. Sep. 17, 2010), ECF No. 79, against UnitedHealth Group (United) and its subsidiary, UnitedHealthcare Medicare & Retirement—the nation’s largest provider of Medicare Advantage (MA) plans. This suit was originally filed in 2011 by a former United Healthcare finance director under FCA, and in accordance to FCA this case was sealed for five years while DOJ investigated the claims. The complaint alleged that United Health engaged in an upcoding scheme by falsifying about the severity of patients’ illness. This case is gaining some attention partly due to practitioners’ curiosity to gauge Attorney General Session’s approach to FCA cases. The New York Times has reported that DOJ’s court notice in this case was filed by a lawyer who joined the Civil Division as a part of Trump administration.

Perhaps it is too early to decipher the Trump Administration’s position on this particular matter.  Yet some early signs suggest the effect of FCA is not waning. In sum, ferreting out fraud and abuse has always enjoyed bipartisan support.  Moreover, the ACA made significant strides towards that bipartisan goal and allowed to recover a record amount of money to the government coffers, and those strengthened provisions of FCA as enacted in ACA will likely remain a tool for the government to maintain the integrity of the healthcare system.

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Preventing Abuse in Long-Term Care Facilities

Up to one in six nursing home residents may be the victim of abuse or neglect every year. In late 2016, the Centers for Medicare and Medicaid Services (CMS) issued a final rule revising the requirements that Long-Term Care Facilities must meet to participate in the Medicare and Medicaid programs. According to CMS’ chief medical officer Dr. Kate Goodrich, “these are the first comprehensive updates to long-term care requirements since 1991.” One section in particular discusses changes to prevent the abuse of residents of Long-Term Care Facilities.

Provisions related to abuse, neglect, and exploitation are now included in a separate section, which brings more attention and focus to these issues. To more accurately reflect the content, § 483.13 regarding abuse in Long-Term Care Facilities has been re-designated and revised to § 483.12. The title has been changed from “Resident Behavior and Facility Practices” to “Freedom from Abuse, Neglect, and Exploitation.” The focus of this regulation is to ensure that residents are not subjected to abuse, neglect, misappropriation of property, and exploitation, and to establish requirements for the facility’s response to any allegations that has occurred. To prevent abuse of residents in Long-Term Care Facilities, we must recognize that abuse continues to occur. Last month, CNN issued a report from an exclusive analysis of state and federal data and interviews with experts, regulators and the families of victims, and found that abuse in nursing homes is far more prevalent than most people know.  The report focused on caregiver-on-resident abuse. Caregivers in nursing homes are in a position of authority and trust, and too often when they violate that position they are not properly reprimanded due to nursing homes being slow to investigate or report allegations, police dismissal, and state regulators failing to flag patterns of repeated allegations against a single caregiver.

A key difference in the new rule expands the list of individuals whom a facility may not employ or otherwise engage. It prohibits facilities from employing individuals who “have been found guilty of abuse, neglect, exploitation, misappropriation of property, or mistreatment by a court of law; have had a finding entered into the State nurse aide registry concerning abuse, neglect, exploitation, mistreatment of residents or misappropriation of their property; or have a disciplinary action in effect against his or her professional license by a state licensure body as a result of a finding of abuse, neglect, exploitation, mistreatment of residents or misappropriation of resident property.” The new rule now also requires that facilities develop and implement written policies and procedures that prohibit and prevent abuse, neglect, exploitation of residents and misappropriation of resident property, and also requires that facilities establish policies and procedures to investigate any allegations of abuse, neglect, exploitation, or misappropriation of property. Furthermore, facilities must establish policies and procedures to ensure reporting crimes, and investigation into any allegations.

With much of the new rule now in effect, residents and families will hopefully see a significant decline in the rate of nursing home abuse, but much will depend on implementation and enforcement. Medicare will issue guidance this summer on exactly how nursing homes must comply.

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In the House: Military Hunger Prevention Act

On February 15, 2017, a bipartisan group of members in the House of Representatives introduced the Military Hunger Prevention Act, a bill that would help active-duty military members qualify for the Supplemental Nutrition Assistance Program (SNAP), more commonly known as food stamps. SNAP was implemented to address food insecurity and access to a sufficient quantity of affordable nutritious food. It was also designed to improve the long-term health and economic well-being of children.

Military members face unique financial challenges inherent to being active-duty, such as costs incurred from changes of station, deployment, and underemployment among military spouses. According to a survey conducted by Blue Star Families (a nonprofit that raises awareness of issues unique to military life) and the Institute for Veterans and Military Families (an interdisciplinary academic institute that publishes research on the social, economic, and policy issues that affect veterans and their families), 75% of active duty spouses reported that being a military spouse has had a negative impact on their ability to pursue employment.

Consequently, active-duty military members have reported facing food insecurity; some have indicated that they are seeking food assistance through a food bank or charitable organization. Yet, thousands of military members and their families are disqualified from SNAP because they receive a monthly Basic Allowance for Housing (BAH), which is then counted as part of their income when their eligibility for SNAP is determined. This is inconsistent with how other federal programs treat the BAH. For instance, the Internal Revenue Service (IRS) does not consider the BAH as earned income for purposes of assessing Earned Income Tax Credit. Nor is it accounted under the Health and Human Services’ Poverty Guidelines, which determines eligibility for other federal benefits programs such as the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) nor the Head Start Program.

It is also worth noting that SNAP is a federal entitlement program, which means that everyone who is eligible for the benefits will receive them. Receiving benefits will not be at the cost of another beneficiary.

The proposed Military Hunger Prevention Act intends to alleviate the food insecurity issue prevalent among active-duty military members who would otherwise qualify if it not for the current provisions under the Food and Nutrition Act of 2008 under 7 U.S.C. 2014(d). Thus, the Act would be an amendment excluding housing allowance “from any calculation of income, assets, or resources” when determining eligibility for any federal program issuing benefits in nutrition assistance.

According to Congresswoman Susan A. Davis, a senior member of the House Armed Services Committee, the Military Hunger Prevention Act would “make good on our national commitment to take care of all those who proudly serve in our armed forces.”

The Act is currently being reviewed by the Committee on House Armed Services and the Committee on House Agriculture.

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Trump, Biotech, and the FDA Drug Approval Process

During his Joint Address to Congress on the evening of February 28, President Donald Trump denounced the decades-old prescription drug approval process, pledging to “slash the restraints” of the current regulatory landscape at the US Food and Drug Administration (“FDA”).  “Our slow and burdensome approval process at the Food and Drug Administration keeps too many advances…from reaching those in need,” President Trump said, giving a nod to his guest, 20-year-old Megan Crowley. Crowley, a college student who was diagnosed with a rare and typically terminal ailment – Pompe Disease – at 15 months old, was not expected to live past age 5. Since her diagnosis, Crowley’s father went on to launch Amicus Therapeutics, a biotechnology company that aims to be the frontrunner of advancing therapies for rare and devastating diseases.  

To many, the President’s harsh opinion of the FDA drug approval process was seen as misleading. Not only is the drug review process in the United States recognized worldwide as the gold standard, FDA is the fastest regulatory agency in the world. Today, the average total review time of a single drug is 8.5 months, down from an average of 30 months in the 1980s.

While most drug and biologic companies must successfully maneuver their compounds through three phases of clinical trials, proving not only safety but efficacy (via two “well-controlled and adequate studies”), there are several other expedited processes that may be utilized to obtain agency approval, at least preliminarily. Breakthrough, priority review, fast track, and accelerated approvals are all programs created to speed up the market availability.

Perhaps most misleading about Mr. Trump’s statements was the approval process for rare diseases like that of Megan. The term “Rare Diseases” is a term of art, defined as afflicting less that 200,000 people nationally. Drug manufacturers of potential treatments of rare diseases, like Pompe, may participate an expedited approval program depending on the seriousness of the ailment. ON the other hand, they may participate in the Orphan Drug Designation process, by which they are incentivized by the FDA to increase research and development on novel drugs via seven years of patent exclusivity, tax credits, and expanded access to Investigational New Drugs (IND). In other words, those who have rare diseases, to the extent to which therapies are being developed, have access to treatment faster than average.

Moreover, many biotech and pharmaceutical companies are skeptical of the deregulation of the industry. “People often argue that the FDA is too restrictive, [but] [w]e have the sense that the balance is pretty right … you have to have a well-characterized risk/benefit profile,” said Roger Perlmutter, head of Research and Development at pharmaceutical heavy hitter Merck. Similarly, Alnylam Pharma CEO John Maragarone stated what, to some, may be obvious: while deregulation seems like a good idea, “payors are looking for evidence of value.” As it is, insurance companies have already shunned some approved treatments that have not demonstrated strong effectiveness.

In 1962, in response to several children dying from ingesting elixir, Congress enacted the Drug Efficacy Amendment to Food, Drug and Cosmetic Act of 1938, explicitly requiring the pre-market approval process to include not only safety profiles, but proof of effectiveness by a showing of substantial evidence. Deviation from this would deem the product false and misleading if placed on the market, and likely open the manufacturer up to liability.

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