Federal Health Care News



On March 6, 2018, UnitedHealthcare announced it will expand pharmacy discounts to millions of its plan participants when they fill prescriptions through retail pharmacies or home delivery.

The new program will apply to over 7 million people enrolled in UnitedHealthcare fully insured commercial group benefit plans, lowering out-of-pocket costs by directly providing consumers with savings from pharmacy manufacturer rebates at the time of purchase.

Beginning Jan. 1, 2019, and on plan renewal thereafter, people enrolled in fully insured group health benefit plans will have discounts applied to their medication cost at the point of sale. The savings will apply to plan participants who are filling a prescription for a drug where the manufacturer provides a rebate. UnitedHealthcare will apply savings from rebates upfront, at the time of sale, to ensure people are paying the lowest amount possible under their plan. Rebates are currently used to keep premiums lower for the benefit of all members and customers, rather than distributed to individual consumers.

In addition to expanding discounts to all fully insured group plan participants, UnitedHealthcare currently supports self-insured customers who choose to implement similar expanded discounts for their employees. OptumRx's stand-alone point of sale solution is also currently available to clients who do not receive their pharmacy benefits through UnitedHealthcare.


On March 15, 2018, The Food and Drug Administration Commissioner Scott Gottlieb announced the agency would take action to lower the nicotine levels in tobacco products.

FDA-funded analysis finds that reducing nicotine levels to 0.04 milligrams per gram of tobacco filler could lower the adult smoking rate from 15 percent to 1.4 percent. As a result, the FDA estimates that 8 million fewer tobacco-related deaths through the end of the century.

The Federal Register notice, will be published on March 16, 2018 and will be open for public comment until June 14, 2018

The nicotine notice will be open for public comment for 90 days. FDA officials are seeking input on what the maximum nicotine level in cigarettes should be and whether such a limit should be implemented all at once or gradually. FDA officials will also consider the potential of a black market in high-nicotine cigarettes this rule would create.  After the comment period ends, officials will decide whether to move forward with a formal proposal.

The 2009 Tobacco Control Act gave the FDA the power to regulate tobacco, though not to ban it.

Gottlieb also announced the FDA plans to issue notices on the role that flavors, including menthol, play in use of tobacco products; and on the regulation of premium cigars.


Data from emergency departments (EDs) show that the U.S. opioid overdose epidemic continues to worsen, according to the latest report by the Centers for Disease Control and Prevention (CDC).

The report examines the timeliest data available to CDC on ED visits for opioid overdoses across multiple states. Overall, ED visits (reported by 52 jurisdictions in 45 states) for suspected opioid overdoses increased 30 percent in the U.S., from July 2016 through September 2017. Opioid overdoses increased for men and women, all age groups, and all regions, but varied by state, with rural/urban differences. The findings highlight the need for enhanced prevention and treatment efforts in EDs and for greater access to evidence-based opioid use disorder treatments, including medication-assisted treatment and harm reduction services.

ED data allow faster tracking of regional and state trends

Data from 16 states in CDC’s Enhanced State Opioid Overdose Surveillance (ESOOS) Program were analyzed, showing quarterly trends by state and rural/urban differences from July 2016 through September 2017. Overall, ED visits for suspected opioid overdoses increased 35 percent in these 16 states hit hard by the epidemic. The data show:

Eight states from three U.S. regions reporting substantial increases—25 percent or greater—in the rate of opioid overdose ED visits.

Significant increases in all states reporting in the Midwest, including Wisconsin (109 percent), Illinois (66 percent), Indiana (35 percent), Ohio (28 percent), and Missouri (21 percent).

Considerable variation among states in the Northeast and Southeast; some states reported substantial increases and others modest decreases:

In the Northeast, large increases were seen in Delaware (105 percent), Pennsylvania (81 percent), and Maine (34 percent), but other states, like Massachusetts, New Hampshire, and Rhode Island showed nonsignificant decreases (<10 percent).

In the Southeast, North Carolina reported an increase (31 percent), while Kentucky reported a statistically significant decrease (15 percent).

Continued rises in cities and towns of all types. Highest rate increases (54 percent) were in large central metropolitan areas (a population of 1 million or more and covering a principal city).

The sharp increases and variation across states and counties indicate the need for better coordination to address overdose outbreaks spreading across county and state borders. Closer coordination between public health and public safety agencies can support identification of changes in supply and use of illicit opioids, further allowing communities to take appropriate action to reduce opioid overdoses.

CDC also examined data from the National Syndromic Surveillance Program (NSSP) BioSense platform, using ESSENCE (Electronic Surveillance System for the Early Notification of Community-based Epidemics) software. Analysis of data from 52 jurisdictions in 45 states, which covers over 60 percent of ED visits in the U.S., found that from July 2016 through September 2017:

All five U.S. regions experienced rate increases; the largest was in the Midwest (70 percent), followed by the West (40 percent), Northeast (21 percent), Southwest (20 percent), and Southeast (14 percent).

Every demographic group experienced substantial rate increases, including men (30 percent) and women (24 percent) and people ages 25-34 (31 percent), 35-54 (36 percent), and 55 or older (32 percent).

A companion editorial “Opportunities for Prevention and Intervention of Opioid Overdose in the Emergency Department,” was also released today in Annals of Emergency Medicine.

For more information about opioid overdose and prevention, please visit www.cdc.gov/drugoverdose.


The U.S. Food and Drug Administration released several guidance documents related to the Nutrition Facts label final rule.

The final guidance explaining how the FDA evaluates the scientific evidence supporting citizen petitions to add certain isolated or synthetic non-digestible carbohydrates to the regulatory definition of dietary fiber.

The FDA published the Nutrition and Supplement Facts Label Final Rule on May 27, 2016. In the rule, it established a definition for the term “dietary fiber” to ensure that only fibers with a beneficial physiological effect on human health could be declared as dietary fiber on the food label. That definition includes naturally occurring fibers like those found in fruits, vegetables, and whole grains, and seven isolated (i.e., extracted from plant sources) or synthetic non-digestible carbohydrates (NDCs), each having a physiological health benefit.

A manufacturer may submit a citizen petition for FDA’s consideration to add a given isolated or synthetic NDC to the FDA’s regulatory definition of “dietary fiber.” The citizen petition should provide scientific evidence that shows the NDC has a beneficial physiological effect on human health.

This final science review guidance will help petitioners understand the level and type of evidence needed to demonstrate whether an NDC has a physiological effect that is beneficial to human health. Such data should be submitted as part of any citizen petition seeking to add a NDC to the definition for dietary fiber.

Reducing the rise in blood sugar or glucose levels after people consume a food or beverage would be an example of a physiological effect that is beneficial to human health. In the final guidance, the FDA clarifies that in order for a study to assess whether an NDC reduces blood glucose and/or insulin levels, the NDC should be added to a food or beverage containing sugar or starch and should not replace any sugars or starches since those refined carbohydrates cause the rise in blood glucose levels. It is also important that the NDC is added to a food or beverage with the same amount of sugar or refined carbohydrate as in the food or beverage that is provided to the study’s control group.

The FDA is moving forward now to respond to citizen petitions requesting that the agency include additional NDCs in the regulatory definition of “dietary fiber,” to finalize the rule regarding the compliance dates for the Nutrition Facts label rules, and to issue several additional technical guidance documents related to nutrition labeling.

In addition to the final science review guidance, the FDA issued a draft guidance about the declaration of added sugars on honey, maple syrup, and certain cranberry products; a final guidance about the labeling of honey and honey products; a final guidance about reference amounts customarily consumed (RACCs); and a small entity compliance guide for the Serving Size final rule.

Resources include:

Statement from FDA Commissioner Scott Gottlieb, M.D. - FDA’s New Efforts to Advance Implementation of the New Consumer Nutrition Facts Label for Foods

Industry Resources on the Changes to the Nutrition Facts Label

Questions and Answers for Industry on Dietary Fiber

Guidance for Industry: Scientific Evaluation of the Evidence on the Beneficial Physiological Effects of Isolated or Synthetic Non-digestible Carbohydrates Submitted as a Citizen Petition (21 CFR 10.30)

Draft Guidance for Industry: Declaration of Added Sugars on Honey, Maple Syrup, and Certain Cranberry Products


In direct response to President Trump’s October 2017 Executive Order, the Departments of Health and Human Services (HHS), Labor, and the Treasury (the Departments) proposed a rule to expand the availability of short-term, limited-duration health insurance by allowing consumers to buy plans providing coverage for any period of less than 12 months.

Currently the maximum period of less than three months.

The proposed rule, if finalized, will provide additional options to Americans who cannot afford to pay the costs of soaring healthcare premiums or do not have access to healthcare choices that meet their needs under current law.

Short-term, limited-duration insurance, which is not required to comply with federal requirements for individual health insurance coverage, is designed to provide temporary coverage for individuals transitioning between healthcare policies, such as an individual in between jobs, or a student taking a semester off from school.

A fact sheet on today’s proposed rule can be found here:  https://www.cms.gov/Newsroom/MediaReleaseDatabase/Fact-sheets/2018-Fact-sheets-items/2018-02-20.html.

The link to the proposed rule can be found here:  https://www.federalregister.gov/documents/2018/02/21/2018-03208/short-term-limited-duration-insurance.


The Centers for Disease Control and Prevention (CDC) released a Report to Congress on The Management of Traumatic Brain Injury (TBI) in Children, detailing the impact a TBI can have on children and their families.

In 2013, there were approximately 640,000 TBI-related emergency department (ED) visits, 18,000 TBI-related hospitalizations, and 1,500 TBI-related deaths among children 14 years of age, and younger. The leading causes of TBI-related ED visits, hospitalizations, and deaths for those 0-14 years of age were unintentional falls and being struck by or against an object, whereas for those 15-24 years of age, the leading causes were motor vehicle crashes and falls. Another common cause of TBI is sports and recreational activities which accounted for an estimated 325,000 TBI-related ED visits among children and teens in 2012.

The report identifies gaps in care, outlines opportunities for action to reduce the gaps, and highlights policy strategies to address the short and long-term consequences of a TBI. The report also highlights:

TBI management as children transition into adulthood;

challenges in accessing pediatric specialists to ensure best care;

research to support management and outcomes; and

the importance of long-term monitoring of children to better understand adult outcomes and how TBIs at specific developmental periods affect post-TBI outcomes.

Congress directed CDC to compile the Report to Congress (RTC) to review the burden of TBI in children, identify gaps in systems of care, and present recommendations for improving outcomes in this vulnerable population


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