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The Keckley Report

The Next Operation Warp Speed: Nutrition

By January 4, 2021March 1st, 2023No Comments

Happy New Year!

According to YouGov’s survey of 1500 adults last month, the most popular New Year’s resolutions for 2021 include doing more exercise (50%), losing weight (48%), saving more money (44%), improving diet (39%), and pursuing a career ambition (21%). It’s essentially the same as last year’s list led by exercising more (46%), improving diet (45%), losing weight (44%), and saving money (41%). And researchers anticipate two of three will abandon their resolutions by the end of January.

Notably. nutrition is always on these lists. In theory, consumers recognize eating healthy foods in the right portions is essential to health. Though many mistake nutrition for dieting, polls show there’s general awareness that eating healthy foods (vegetables, fruits, whole grains, lean meat and poultry, low-fat dairy and nuts and vegetable oils) instead of food loaded with saturated fats and sodium along with excessive consumption of alcohol is key. But it’s difficult for many, especially during a pandemic. Consider:

  • The pandemic has cut income for 1 in three households: It’s a K economy. Investors fared well as stocks recovered from 30% drop in March to close the year at record highs. The S&P 500 was up 16.3%, the Dow up 7.3%and the NASDAQ up 44%. But 19 million lost their jobs; 4 million businesses closed, and gig workers saw their income cut by up to half. Not surprisingly, food insecurity in households soared doubling 10.5% of all U.S. households to 23% of all households, and tripled in households with children (29.5%). That means more than 100 million Americans are challenged to put any food on the table for their families—whether healthy or not.

  • Food costs for most of the healthier foods are increasing faster than prices for unhealthy foods: for the “average household, food purchases for home consumption represents 9% of their discretionary spending, but for low-income families, it’s 36%. And complicating matters, while l food costs have increased at a nominal rate of 2% per year for the last 20 years, prices for fresh vegetables have increased at 3-4% annually—higher than any other food category. For many, “choosing wisely” isn’t an option due to costs

Lack of attention to nutrition in the U.S. health system has reached pandemic proportion: according to the 2017–2018 National Health and Nutrition Examination Survey (NHANES) released last month, the prevalence of obesity in American children, adolescents, and adults is higher than it has ever been in nearly 60 years:

  • Among adults, in 1960-1962, 13.4% of adults were obese and 31.5% were considered overweight; less than 1% had severe obesity. Today, 42.4% of U.S. adults aged 20 and over are obese up 12% since 2000, including 9.2% are severely obese, and 30.7% are overweight.

  • Among children, 19.3% of Americans ages 2-19 are obese, and a third of these severely obese. And another 16.1% of U.S. children are overweight. Obese children tend to become obese adults.

The report cautions that “Complex relationships between genetic, socioeconomic, and cultural influences can contribute to obesity, and eating patterns, urban development, and lifestyle habits can influence its prevalence.”

In healthcare, nutrition has not been addressed as a priority. It’s considered a risk factor in diagnoses for heart disease, renal disease and Type 2 diabetes among adults and a correlate to mental health issues for overweight kids, but it’s rarely treated as a root cause for health problems that disproportionately impact under-served cohorts in our society. Food insecurity is getting attention as a “social determinant to health” and by some Medicare Advantage plans, but for the most part, the healthcare delivery system and regulators have not effectively advanced nutrition as the central element of our population’s health. Here’s the most recent example:

Last Tuesday, the federal government issued its new dietary guidelines that are updated every 5 years. The USDA in collaboration with other federal agencies rejected its independent scientific committee’s recommendations to lower the limit for added sugars in the diet to 6% of daily calories from 10%, lower the limit for alcoholic beverages for men to one drink per day from two (matching guidance for women) and advising that children under age 2 consume no added sugars at all that are prevalent in processed foods. The U.S. Departments of Agriculture and Health and Human Services explained that “the new evidence is not substantial enough to support changes to quantitative recommendations for either added sugars or alcohol” while acknowledging significant pushback from industry groups that opposed changes.

In the Healthy People 2020 Progress Report, improvement in Nutrition and Weight Status from 2010 to 2020 was negligible: of the 43 initiatives being pursued targeted for improvement to the overall health status of the U.S. population, it was among the bottom 5. Only 1 of the 31 milestones set for Nutrition and Weight Status improvements had been met and on 21 measures, there’s no improvement at all. That’s where we are.

MY TAKE

Nutrition is complicated: eating healthy foods routinely costs more than eating food that’s not so nutritious. Knowing which foods are nutritious is not simple: food literacy is woefully inadequate. And even more complicated is the healthiness of the food supply chain—ingredients, manufacturing, storage, and preparation has become industrialized to maximize appeal, profits and margins and minimize spoilage.

Since 1990, inter-agency cooperation has been coordinated through the National Nutrition Monitoring and Related Research Act (NNMRR). It’s time to revisit the regulatory framework that impairs the necessary attention nutrition deserves in our health system What’s needed is an Operation Warp Speed to address the nutrition pandemic that’s harming one in three Americans and increasing avoidable healthcare costs for all.

This effort must be comprehensive: how we teach “health” to children in schools and homes, how we train clinicians in training, how we use diagnostic tools to examine food insecurity and nutrition, how we manufacture foods, how evidence-based dietary supplements can be integrated and rogue products identified and eliminated, how alcoholic beverage consumption complicates healthiness, how nutrition is covered in insurance plans, how preventive and primary care proactively addresses nutrition and more.

52% of U.S. land and 80% of our territorial waters are devoted to food production. It’s an industry that’s dominated by corporate interests that produce, package, and sell the food we eat. It deserves fresh attention as our healthcare system grapples with nutrition.

The next Operation Warp Speed should be focus on the state of nutrition in the U.S.

Paul

PS For the next month, ads for weight loss programs will dominate TV filling the void left from the Campaign 2020 ad war. According to USNWR, which uses an expert panel to assess 35 diets in 7 categories, the Best Diets for Weight Loss are Weight Watchers, Vegan, Volumetrics, Flexitarian and Jenny Craig BUT the “Best Diets for Healthy Eating” which combines nutritional completeness and safety ratings include Dash, Mediterranean, Flexitarian, MIND and TLC. It cautions “Not all diet plans are nutritious and safe”—a timely reminder. Happy New Year!

RESOURCES

“Exercising and sticking to a healthy diet are the most common 2021 New Year’s resolutions”; December 2020; YouGov

“Prevalence of Overweight, Obesity, and Severe Obesity Among Adults Aged 20 and Over: United States, 1960–1962 Through 2017–2018” December 11, 2020; National Center for Health Statistics

“New U.S. Dietary Guidelines Reject Recommendation to Cut Sugar, Alcohol Intake Limit”; December 29, 2020; Wall Street Journal

U.S. Department of Agriculture Economic Research Service

“Household Pulse Survey: Phase 3” United States Census Bureau

Q3 2020 Data: Bureau of Economic Analysis, US Department of Commerce

U.S. Department of Agriculture- Food and Nutrition

“Food Price Index 2020” U.S. Department of Agriculture

“How Much Has Food Insecurity Risen? Evidence from the Census Household Pulse Survey”; June 10, 2020; Northwestern Policy Research

“Best Weight-Loss Diets, 2020 Best Diets” US News

CORONAVIRUS NEWS

Key stats: January 4, 2021

  • The 7-day average in the U.S. through January 3, 2021: 1.544 million tests/day, 208,449 positive cases per day, 124,390 hospitalized/day, and 2,611 deaths/day.

  • Currently, two vaccines made by Pfizer and BioNTech and Moderna are approved for emergency use authorization in the U.S. and a third by Novavax started its Phase 3 clinical trial December 28.

  • Worldwide, researchers are currently testing 64 vaccines in clinical trials on humans, and 20 have reached the final stages of testing. At least 85 preclinical vaccines are under active investigation in animals.

“Coronavirus Vaccine Tracker”; January 4, 2021; New York Times

The COVID-19 Tracking Project January 4, 2021

Hospitals get $3B in Latest COVID-19 Relief Package

In the latest Covid-19 relief funding bill signed into law December 27, $3 billion of the $900 billion was earmarked for hospitals, clinics, and other health-care providers to offset their revenue losses and higher expenses as a result of the pandemic. A current debate is how racial differences in patient populations is considered in disbursements since revenue loss considerations might favor hospitals that charge more to privately insured patients which are disproportionately white.

Note: This is the 5th Relief fund authorized by Congress. About $25 billion hasn’t been spent of the $175 billion appropriated to providers in the CARES Act Provider Relief Fund last spring.

Melanie Evans “Latest Covid-19 Aid Package Scales Back Funds to Hospitals, Clinics” Wall Street Journal January 1, 2021; Wall Street Journal

INDUSTRY NEWS

Hospitals Lose Court Challenge to Price Transparency Rule

Last Tuesday, U.S Court of Appeals of the District of Columbia Circuit rejected hospital advocates’ appeal in the case of the American Hospital Association, et al. v Azar, in which a lower court upheld the price transparency requirements. Those rules require that on Jan. 1, 2021, all hospitals post online the rates they negotiate with all accepted health plans for each hospital item and service, as well as individual health plan rates for 300 “shoppable” services. In effect, the court rejected AHA’s argument that the Affordable Care Act (ACA) authorized only the release of chargemaster rates agreeing with the federal government’s argument that the list of 300 shoppable services is a subset of the first list.

The AHA is likely to ask the full circuit court to reconsider the ruling, arguing the requirement imposes significant costs on providers. Hospital penalties top out at a maximum one-year fine of $109,500 for noncompliance.

“Hospitals lose another attempt to stave off price transparency”; December 29, 2020; Healthcare Dive

“Hospitals lose appeal in price transparency case”; December 29, 2020; Becker’s Hospital Review

HHS Changes Stark Law, Anti-Kickback Regs to Enable Risk Sharing with Physicians

Last week, the HHS Office of the Inspector General published two final rules that aim to reduce regulatory barriers to care coordination and value-based arrangements with physicians: “Revisions to the Safe Harbors Under the Anti-Kickback Statute and Civil Monetary Penalty Rules Regarding Beneficiary Inducements” and “Modernizing and Clarifying the Physician Self-Referral Regulations.” The rules…

  • Clarify how medical device manufacturers and durable medical equipment companies may participate in protected care coordination arrangements that involve digital health technology.

  • Lowers the level of “downside” financial risk parties must assume to qualify under the new safe harbor for value-based arrangements that involve substantial downside financial risk.

  • Broadens the new safe harbor for cybersecurity technology and services to protect cybersecurity-related hardware.

  • Enables a range of arrangements to improve the coordination and management of patient care and the engagement of patients in their treatment if all applicable regulatory conditions are met.

“CMS and HHS-OIG Issue Final Rules for Anti-Kickback Statute and Stark Law”; December 17, 2020; Kirkland & Ellis

Federal Court Grants Delay in Implementation of Most Favored Nation (MFN) Drug Pricing Rule

On November 27, CMS issued the MFN Rule which revised Medicare Part B reimbursement methodology for certain drugs to align with the lowest international price among a group of countries effective January 1, 2021. On December 23, 2020, Judge Catherine Blake of the U.S. District Court for the District of Maryland granted the Pharmaceutical Research and Manufacturers of America (PhRMA) a 14-day nationwide temporary restraining order, preventing implementation of the MFN rule. And on December 28, 2020, Judge Vince Chhabria of the U.S. District Court for the Northern District of California granted California Life Sciences Association (CSLA) a preliminary injunction prohibiting CMS from implementing the MFN Rule based on a failure to follow notice and comment procedures under Administrative Procedure Act (APA).

Most Favored Nation Model; December 28, 2020; CMS Innovation Center

Study: Opioid Use Common Among a Fourth of Young Adults

Researchers studied opioid use among 1252 non-Hispanic White individuals and American Indian individuals in rural counties in the central Appalachia region of North Carolina from January 1993 to December 2015. Findings:

  • By age 30 years, 24.2% (322 participants) had used a non-heroin opioid, 8.8% (155) had used a non-heroin opioid weekly and 6.6% (95) had used heroin.

  • Childhood risk markers for later opioid use included male sex, tobacco use, depression, conduct disorder, cannabis use, having peers exhibiting social deviance, parents with legal involvement, and elevated systemic inflammation.

  • Among young adults with opioid use, those with heroin use had the highest rates of childhood psychiatric disorders and comorbidities.

Shanahan et al. “Prevalence and Childhood Precursors of Opioid Use in the Early Decades of Life”; December 28, 2020; JAMA Pediatrics

Opioid Overdoses Up during Pandemic

The Overdose Detection and Mapping Application Program showed 16% more overdoses in February 2020 than February 2019, escalating to 42% more in May 2020 compared with May 2019.

A recent national review of more than 73 million patient records found that patients with COVID-19 infection and substance use disorders had greater hospitalization (41% vs 30%) and death rates (9.6% vs 6.6%) than patients with COVID-19 without substance use disorders.

Thomas R. Kosten, Ismene L. Petrakis; “The Hidden Epidemic of Opioid Overdoses During the Coronavirus Disease 2019 Pandemic”; December 30, 2020; JAMA Psychiatry

Study: Outcomes Better for Richest 5% in the U.S.

Researchers compared the health outcomes of white US citizens living in the 1% and 5% richest counties of the U.S. to the health outcomes of average residents in 12 other developed countries (Australia, Austria, Canada, Denmark, Finland, France, Germany, Japan, the Netherlands, Norway, Sweden, and Switzerland). Key findings:

  • White US citizens in the 1% and 5% highest-income counties obtained better health outcomes than average US citizens but had worse outcomes for infant and maternal mortality, colon cancer, childhood acute lymphocytic leukemia, and acute myocardial infarction compared with average citizens of other developed countries.

  • For 6 health outcomes, the health outcomes of White US citizens living in the 1% and 5% richest counties are better than those of average US citizens but are not consistently better than those of average residents in many other developed countries, suggesting that in the US, even if everyone achieved the health outcomes of White US citizens living in the 1% and 5% richest counties, health indicators would still lag behind those in many other countries.

Emmanuel et al “Comparing Health Outcomes of Privileged US Citizens With Those of Average Residents of Other Developed Countries”; December 28, 2020; JAMA Internal Medicine