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NCL Health Podcast Series: Amy Hinojosa, National CEO of MANA

NCL is excited to present the inaugural podcast episode of our new Health Podcast Series under the “We Can Do This!” podcast umbrella, hosted by our Senior Director of Health Policy Robin Strongin. This month we are celebrating National Hispanic Heritage Month with our esteemed guest Amy Hinojosa, National President & CEO of MANA.

Obesity medicine specialists, health providers, insurers and employers urged to make obesity treatment a right of all Americans

October 13, 2023

Media contact: National Consumers League – Nancy Glick, nancyg@nclnet.org, 202-823-8442 NCOA –Simona Combi, Simona.combi@ncoa.org, 571-527-3982

Washington, D.C. – With growing evidence that U.S. adults with obesity feel stigmatized and ignored by their health care providers, the National Consumers League (NCL) and National Council on Aging (NCOA) today urged health professionals, insurers and employers to join a national movement to define quality obesity care as a right for every American.

Taking the case directly to health professionals on the front lines in delivering obesity care, NCL and NCOA used The Obesity Society’s annual meeting in Dallas October 14-17 to announce plans to provide Americans with an Obesity Bill of Rights.  Today, over 100 million adults are living with obesity[1] (42 percent of the public), yet only 10 percent get help from medical professionals.[2] An Obesity Bill of Rights has the potential to transform obesity care by empowering Americans to demand the respect of their health providers and to be screened, diagnosed, and effectively treated for their obesity based on medical treatment guidelines.

“For too long, adults with obesity have encountered a healthcare system that works against them. They are stigmatized, discriminated against, not treated with respect by their health providers, and confront significant obstacles in receiving the care they deserve. ” said Sally Greenberg, Chief Executive Officer of the National Consumers League. “This must change; we need an overhaul of the health system, and we believe an Obesity Bill of Rights can drive this transformation.”

Because this change will only happen if there is agreement on a set of basic rights that ensure adults with obesity receive respectful, timely, and effective obesity care, NCL and NCOA unveiled www.Right2ObesityCare.org, a new online engagement platform, so the nation’s health providers, insurers and employers can play a role in developing the Obesity Bill of Rights.  Right2ObesityCare.org explains the purpose and research-driven process and encourages a wide range of health professionals – from obesity medicine specialists and physicians to dietitians, nutritionists, exercise physiologists, health educators, and mental health professionals – to contribute their ideas.

Town Halls Chart the Obstacles for Adults with Obesity and Their Providers

Along with hearing from health professionals, the Obesity Bill of Rights will be informed by the insights of both adults with obesity and their health providers who participated in four town hall meetings that NCL and NCOA hosted across the country. Held in senior centers and churches in

California, Delaware, Mississippi, and Oklahoma between June and August 2023, the town halls involved more than 250 older adults, community leaders, and local clinicians who laid bare a healthcare system that is inhospitable to delivering quality obesity care.                                                        

When asked to share their experiences, older adults attending the town halls spoke of feeling invisible when seeing a health provider, not being listened to, and being treated with disdain when they initiated conversations about their obesity. At the same time, physicians described feeling inadequate to provide obesity care due to the limited time for counseling, not enough training in obesity management, inadequate coverage and reimbursement for obesity care, and needing better tools to help patients recognize obesity risks. This confirms research that finds adults with excess weight often feel unwelcome in the doctor’s office or believe that seeking help for obesity signifies moral failure. [3]

“This is a chronic condition that no one wants to talk about,” said Ramsey Alwin, NCOA President and CEO. “For several decades, NCOA has worked to empower older adults to better manage their chronic conditions. To break down barriers related to obesity, we held town halls that allowed both older adults and their health providers to relay their lived experiences. What we learned is that encouraging more people to seek obesity care requires an investment in science-based, easy-to-understand, accessible information about obesity; a healthcare system that encourages informed decision-making and patient-centered care; and effective public policy that requires health plans to provide access to the treatments deemed appropriate by the health provider, including lifestyle interventions, FDA-approved weight loss medications, and bariatric surgery.”

Mobilizing for Change
With the townhalls as a guidepost, NCL and NCOA are now leading a rigorous process to finalize and release the Obesity Bill of Rights to the medical community and public before the end of 2023. The process includes hosting a meeting of top experts to review a preliminary draft with recommendations for refinement. NCL and NCOA will also seek feedback from specialists in minority health, aging, and rural health, as well as health professionals and other stakeholders who offer advice through the online engagement platform.

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About NCL

The National Consumers League, founded in 1899, is America’s pioneer consumer organization. The organization’s mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.

About NCOA

The National Council on Aging (NCOA) is the national voice for every person’s right to age well. We believe that how we age should not be determined by gender, color, sexuality, income, or ZIP code. Working with thousands of national and local partners, we provide resources, tools, best practices, and advocacy to ensure every person can age with health and financial security. Founded in 1950, we are the oldest national organization focused on older adults. Learn more at www.ncoa.org.

[1] Hales CM,, et al. Prevalence of Obesity and Severe Obesity Among Adults: United States, 2017-2018. Centers for Disease Control and Prevention. NCHS Data Brief. No. 360. February 2020.

[2] Stokes A, et al. Prevalence and Determinants of Engagement with Obesity Care in the United States. Obesity. Vol. 26, Issue 5; May 2018, 814-818

[3] Gunther S, et al. Barriers and enablers to managing obesity in general practice: a practical approach for use in implementation activities. Qual Prim Care. 2012; 20: 93-103

Guest Blog: Standardizing portions could help stem the obesity epidemic

By Deborah A. Cohen, MD, MPH

The past few decades have seen dramatic changes in the food environment and food behaviors, all resulting in the epidemics of obesity and diet-related chronic diseases.  About 72% of American adults are overweight or obese and more than half have diet-related chronic diseases. Our research shows that the food environment actually encourages people to eat impulsively and markets twice as much food as people need to maintain a healthy weight.  Our diets are largely influenced by the relative supply and availability of different food products, by marketing, and by other factors we aren’t even aware of.1-3  Restaurants are among the largest risk factors for a poor diet.

Here’s a rather shocking statistic: most Americans dine out between 4-5x per week and, on average, spend 55% of all their food dollars on meals and snacks away from home.4,5  The problem is that away-from-home meals are often inferior in nutritional quality to meals prepared at home – they tend to be higher in salt, fat, and calories, and lower in fruit, vegetables, and whole grains; they also typically include 2-3 times more calories than we need to maintain a healthy weight.6,7  Indeed, portion sizes have been increasing substantially over the past three decades.8

When people dine away from home, their ability to control portion sizes, and thus caloric intake, is limited. Studies demonstrate that we all eat more when we are served more. 9,10   As portion size increases, calories go up. The results are stunning:  Laboratory based studies in both adults,11,12 and children13,14 show that when larger portion sizes are served, calories go up as much as 30% with no differences in self-reported hunger.  So eating out – which we do a lot more than we used to – is a major contributor to weight gain and increases the risk of obesity and chronic diseases.6 Multiple studies support the association between frequency of meals consumed in restaurants and the risk for overweight.15-18

My research looks at how portion sizes can be made transparent and predictable with the hope that this would have an enormous benefit for America’s obesity crisis. Smaller, standardized portions are a practical and feasible solution to help stem the obesity epidemic.

Portion control has also proven to be an effective measure to reduce the amount – and therefore the harm – of alcohol consumption.19,20 Alcoholic beverages are classified by the percentage of alcohol content and the U.S. government defines a standard drink as containing 0.6 oz. of alcohol. Standard drink sizes are 12 ounces for a standard beer, 5 ounces for a glass of wine, and 1.5 ounce shot of 80 proof spirits.  These standard portion sizes allow us to measure a standard drink and to limit the risk of inebriation. Many states mandate that alcohol be served in standard portions; twelve states also require that larger portions of alcohol carry a higher price.21  Applying these principles to food could be an enormous aid, since people are not reliably able to judge what constitutes an appropriate individual portion just by looks.22-24 Standard portions are also a necessity for medications.  Many consider food as “medicine”, so applying portion standards to food is a natural extension that could improve health outcomes. That was our goal.

Piloting the Solution: Standardized Portions

Under a National Institutes of Health funded planning grant, my colleagues and I  developed guidelines for standard portions .  With input and guidance from an advisory board composed of nationally recognized nutrition researchers, we set calorie limits for meals at 700 calories each for lunch and dinner, 500 calories for breakfast and 200 calories for snacks.  We separated meal components into appetizers (150 calories), soups (150 calories), dressings and salads (150 calories), plain entrees (200 calories) for breakfast, lunch and dinner, mixed entrees (350 calories), non-starchy sides (100 calories), starchy sides (150 calories), beverages and desserts (100 calories).25

We conducted a pilot study with three local restaurants in Southern California. We incentivized these establishments to create an alternative menu to their usual offerings, providing meals in quantities that met the above caloric guidelines. We offered restaurants a $2000 participation fee as well as paying for all the costs of the menu development and printing, and purchasing gift cards to offer customers as part of the evaluation. The restaurants created new “Balanced Portions” menus, which included 6-8 items from their regular menu. The meals were not intended for weight loss purposes, but are only designed to prevent unintended overconsumption.

We began our pilot project by  asking restaurant managers to identify which menu items were the most popular. The project did not change any preparation or recipes. Not surprisingly, even though we would be reducing the quantity of some items served and increasing the quantity of others, none of the restaurants were interested in reducing the price of any item for offering less.

One restaurant did not want to change the price or the quantity, we plated the calorically set portions and then had them pack the remaining food for carry out.   (see Figure 1, top menu.) When we measured the original food quantities, in most cases the amounts served were double the guidelines for a single meal, so leftovers were sufficient for a second meal. The meal was marketed as “Dinner today, Lunch tomorrow”.

The other two pilot restaurants were not interested in packing up extra food, so they created an alternative menu by selecting menu items that already met the guidelines. The owners came up with new prices comparable to other selections on the menu. At yet another restaurant, the regular menu only included entrees and sides, so to get variety, people needed to order several large dishes. The new menu allowed people to get variety with one order. In all cases we requested that each meal contain at least one cup of vegetables. We piloted this with 3 restaurants: First Szechuan Wok, Dave’s Deli & Catering, and Delhi Belly. (Figure 1)

Once we verified the quantity of food to be plated as a serving size, we sent the meals out for calorimetry (measures calories) to verify that the calories would be <700.  All the meals met the criteria. We then held a training session for restaurant staff and provided written guidelines on food to be plated for each menu item. We provided restaurants with measuring cups and kitchen scales so they could meet the guidelines. The plates were full, as we generally increased the quantity of vegetables and reduced the quantity of meats and starchy sides. The restaurants all passed the training session.

Feedback from Customers. Once the menus were launched and made accessible to patrons, we invited customers to provide feedback on the menus and their experience and offered them gift cards from the restaurant for their participation, whether or not they ordered from the Balanced Portions Menu.

Overall, the feedback on the alternative Balanced Portions menus from customers was positive. We conducted in-person and phone interviews with 33 customers (56% ordered from the Balanced Portions menu) who dined at one of the three restaurants. Findings from the one-on-one interviews revealed that 16 of the 18 customers who ordered from the Balanced Portions expressed satisfaction with their meals and shared that they “would love” to see Balanced Portion menus offered at other restaurants. In addition, the availability of Balanced Portions menu may help them reduce food waste, maintain healthy eating habits, and meet recommended dietary guidelines. Interestingly, among those who ordered from the regular menu, one participant described the portions as “very generous” and more than half reported going home with leftovers.

However, some of the interviewees expressed concerns regarding cost and thought lowering the prices and offering more Balanced Portion menu options may encourage more people to opt for standardized portions. Some participants thought eliminating to-go options and offering smaller portions at lower prices would be most  appealing.

Adherence to Portion Sizes. We also assigned a research assistant (RA) to be a “secret shopper.” The RA ordered Balanced Portions meals to-go and then carefully measured each component with measuring cups and kitchen scales to determine adherence to the guidelines previously issued. In all but one case, the restaurants were adherent to the guidelines. At Delhi Belly they did give a little extra rice, and we advised the owner to be serve a bit less rice.

Conclusion: Our results were very promising.  We concluded that it is highly feasible for restaurants to offer meals with standard portions that reduce the risk of overconsumption, overweight and obesity associated with dining out. We also concluded that we will need more attention to the issue of Balanced Portions menus over time to inform future rollouts at a national level.  Furthermore, understanding the impact on customer attitudes and behavior will provide critical insights into how to scale this in the future. This research is a rewarding and promising first step, full of opportunities to effectively address the obesity crisis and its connection to eating food outside of home.

  1. Milliman RE. Using background music to affect the behavior of supermarket shoppers. Journal of Marketing. 1982;46(3):86-91.
  2. Milliman RE. The influence of background music on the behavior of restaurant patrons. Journal of Consumer Research. 1986;13(2):286-289.
  3. Curhan RC. The relationship between shelf space and unit sales in supermarkets. Journal of Marketing Research. 1972;9:406-412.
  4. Kant AK, Whitley MI, Graubard BI. Away from home meals: associations with biomarkers of chronic disease and dietary intake in American adults, NHANES 2005-2010. Int J Obes (Lond). 2015;39(5):820-827.10.1038/ijo.2014.183
  5. Saksena MJ, Okrent AM, Anekwe TD, et al. America’s Eating Habits: Food Away From Home. In. Wash, DC: USDA; 2018:https://www.ers.usda.gov/webdocs/publications/90228/eib-90196_summary.pdf?v=98073.90222
  6. Lin BH, Frazao E. Away-from-home foods increasingly important to quality of American diet. ERS/USDA. 1999;http://www.ers.usda.gov/Publications/AIB749/.
  7. Rosenheck R. A systematic review of a trajectory towards weight gain and obesity risk. Obes Rev. 2008;9(6):535-547.
  8. Nielsen SJ, Popkin BM. Patterns and trends in food portion sizes, 1977-1998. JAMA. 2003;289(4):450-453.
  9. Rolls BJ, Roe LS, Meengs JS. Larger portion sizes lead to a sustained increase in energy intake over 2 days. J Am Diet Assoc. 2006;106(4):543-549. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=16567150
  10. Diliberti N, Bordi PL, Conklin MT, Roe LS, Rolls BJ. Increased portion size leads to increased energy intake in a restaurant meal. Obes Res. 2004;12(3):562-568. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=15044675
  11. Rolls BJ, Morris EL, Roe LS. Portion size of food affects energy intake in normal-weight and overweight men and women. Am J Clin Nutr. 2002;76(6):1207-1213. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=12450884
  12. Kral TV, Roe LS, Rolls BJ. Combined effects of energy density and portion size on energy intake in women. Am J Clin Nutr. 2004;79(6):962-968. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=15159224
  13. Rolls BJ, Engell D, Birch LL. Serving portion size influences 5-year-old but not 3-year-old children’s food intakes. Journal of American Dietetic Association. 2000;100:232-234.
  14. McConahy KL, Smiciklas-Wright H, Birch LL, Mitchell DC, Picciano MF. Food portions are positively related to energy intake and body weight in early childhood. . Journal of Pediatrics. 2002;140:340-347.
  15. Ayala GX, Rogers M, Arredondo EM, Campbell NR, Baquero B, Duerksen SC, Elder JP. Away-from-home food intake and risk for obesity: examining the influence of context. Obesity (Silver Spring, Md). 2008;16(5):1002-1008. http://search.ebscohost.com/login.aspx?direct=true&db=cmedm&AN=18309297&site=ehost-live
  16. McCrory MA, Fuss PJ, Hays NP, Vinken AG, Greenberg AS, Roberts SB. Overeating in America: association between restaurant food consumption and body fatness in healthy adult men and women ages 19 to 80. Obes Res. 1999;7(6):564-571.
  17. Jeffery RW, French SA. Epidemic obesity in the United States: are fast foods and television viewing contributing? Am J Public Health. 1998;88(2):277-280.
  18. Hornick BA, Krester AJ, Nicklas TA. Menu modeling with MyPyramid food patterns: incremental dietary changes lead to dramatic improvements in diet quality of menus. J Am Diet Assoc. 2008;108(12):2077-2083. http://search.ebscohost.com/login.aspx?direct=true&db=cmedm&AN=19027412&site=ehost-live
  19. Voas RB, Fell JC. Preventing alcohol-related problems through health policy research. Alcohol Research & Health. 2010;33(1-2):18-28. http://search.ebscohost.com/login.aspx?direct=true&db=psyh&AN=2010-23622-003&site=ehost-live
  20. Anderson P, Chisholm D, Fuhr DC. Effectiveness and cost-effectiveness of policies and programmes to reduce the harm caused by alcohol. Lancet. 2009;373(9682):2234-2246. http://search.ebscohost.com/login.aspx?direct=true&db=cmedm&AN=19560605&site=ehost-live
  21. NHTSA. Preventing Over-consumption of Alcohol – Sales to the Intoxicated and “Happy Hour” (Drink Special) Laws http://www.nhtsa.dot.gov/people/injury/alcohol/PIREWeb/images/2240PIERFINAL.pdf. 2005.
  22. Levitsky DA, Obarzanek E, Mrdjenovic G, Strupp BJ. Imprecise control of energy intake: absence of a reduction in food intake following overfeeding in young adults. Physiol Behav. 2005;84(5):669-675. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=15885242
  23. Levitsky DA, Youn T. The more food young adults are served, the more they overeat. J Nutr. 2004;134(10):2546-2549. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=15465745
  24. Wansink B, Painter JE, North J. Bottomless bowls: why visual cues of portion size may influence intake. Obes Res. 2005;13(1):93-100. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=15761167
  25. Cohen DA, Story M, Economos C, Ty D, Martin S, Estrada E. Guidelines for Standard Portions in Away-From-Home Settings In:2023.

Unveiling the flaws in the 340B Drug Pricing Program: Hospitals, medical debt, and consumer struggles

Sally Greenberg

By Sally Greenberg, Chief Executive Officer

In 1992, Congress created the 340B Drug Pricing Program to help ensure vulnerable patients would be able to access medications they need but may not be able to afford. This program provides steeply discounted drugs to health care providers – mostly hospitals – serving low-income patients with the intent that the providers would pass those discounts along to patients. Unfortunately, that is not what is happening. The National Consumers League (NCL) is increasingly concerned about this program, especially as it relates to hospitals’ abusive and aggressive debt collection practices, and how those practices lead to consumer medical debt. A recent letter from a bipartisan group of Senators underscores hospitals’ role in this growing problem.

We find it particularly troubling that many hospitals benefiting from 340B are not only nonprofit entities but are designated as charity hospitals – supposedly caring for low income and indigent patients. A 2022 report by the Alliance for Integrity and Reform of 340B found that charity care spending for nearly two-thirds of 340B hospitals was less than the national average for similar hospitals. Further, a December 2019 Government Accountability Office (GAO) report found that “some nongovernmental hospitals that do not appear to meet the statutory requirements for program eligibility are participating in the 340B program and receiving discounted prices for drugs for which they may not be eligible.” One report found that 82% of nonprofit hospitals spent less on community programs than the value of their tax exemptions.

Consumers are not benefiting from the 340B program in the way Congress intended. A patient whose income is above 200 percent of the Federal Poverty Level (FPL) is expected to pay full price for a drug they receive at the hospital, even though the care center from which they are “buying” the drug did not pay full price for it. Hospitals participating in the 340B program saved an average of $11.8 million per year, according to a 2019 report from Beckers Hospital Review, and multiple studies have found that a majority of hospitals markup medicines between 200-500 percent. Under the current program, an individual who makes $29,200 per year has to pay that price.

What is even more alarming is the fact that if a patient can’t pay, the hospitals that have benefited enormously from discounted drugs intended for vulnerable patients are aggressively suing these same patients. This illustrates a major disconnect between the intent of the 340B program and the way it is operating today.

While estimates differ, medical debt is believed to cause more than 60 percent of bankruptcies in America. Most consumers facing medical debt did not end up in that situation because of bad decisions or profligate spending. Most have had some kind of injury or unexpected illness and don’t have insurance – or don’t have sufficient insurance – to cover their medical and hospital costs. Patients who need financial assistance should be processed when entering the hospital for medical care. Many are not given the chance to do so and as a result, can be sued for debt after services are rendered. Medical debt collection practices are debilitating for low-income consumers and can destroy their credit ratings, subjecting them to subprime rates and a never-ending spiral of debt.

Even if patients don’t start out poor, because of excessive fees, penalties, and other costs added onto what may or may not be actual medical debt on the part of patients, aggressive debt-collection practices can leave them destitute. Many don’t have funds to hire a lawyer, and if summoned, they often don’t know they need to actually go to court; in fact, sometimes debt collectors advise them not to show up in court. As a result, default judgments are filed against them, leading to garnishments of wages, and liens on homes, cars, and other properties. In 2019, the Journal of the American Medical Association studied the garnishment of wages by hospitals in the state of Virginia and found that 71% of the hospitals were nonprofit and the gross mean annual revenue of hospitals engaged in garnishments was $806 million, with 8,399 patients having wages garnished.

Below are just a few stories illustrating hospitals’ medical debt collection practices playing out in communities throughout the nation.

  • A woman in Knoxville, Tennessee, was diagnosed with cancer and underwent surgery and chemotherapy. Even though she had health insurance, she was left with almost $10,000 in medical bills that she couldn’t pay. Financial counselors told her she couldn’t schedule cancer checkup appointments with her doctor until she has a plan to pay her bills, according to a December 2022 story by NPR.
  • As reported by the Washington Post in May 2019, an investigation by the Baltimore Sun found that 46 hospitals in Maryland filed more than 132,000 lawsuits for unpaid medical bills from 2003 to 2008 and won at least $100 million in judgments. In some cases, hospitals added annual interest at twice the rate permitted for other types of debts or placed liens against patients’ homes.
  • The Washington Post reported in 2019 that the University of Virginia (UVA) Health System sued former patients more than 36,000 times for over $106 million over a six-year period. During that time, UVA’s Medical Center earned a $554 million profit and held stocks and other investments worth $1 billion. One of the patients the UVA Health System sued was Heather Waldron. Following emergency surgery and other treatment in 2017 to address an intestinal malformation, Waldron received a bill from the University of Virginia Health System for $164,000, more than twice what a commercial insurer would have paid for the care. When she was unable to pay, the UVA Health System pursued her with a lawsuit and a lien on the home she shared with her then-husband and five children. In the fall of 2019, the family lost their home, and the “financial disaster” contributed to Waldron and her husband divorcing earlier that year.

We support the critical role hospitals play in communities across the country and understand many dutifully provide charity care to those who cannot pay. However, we believe that if hospitals are designated charity entities and are receiving 340B discounts, they should be required to prove that those discounts have been passed along to patients. The current situation is unacceptable and merits an in-depth investigation and tightening up of the 340B rules. Charity hospitals should not be able to both claim 340B status and drag the very populations they are pledged to serve into debt collection proceedings, taking their homes, their cars, and their possessions in the process. Changes need to be made to ensure that only eligible hospitals are allowed to participate in the 340B program and that the deep discounts for medicines are passed along to patients, as Congress intended.

National Consumers League response to the Request for Information regarding FDA regulation of CBD

August 25, 2023

Media contact: National Consumers League – Katie Brown, katie@nclnet.org, 202-823-8442

Washington, D.C. – On August 17, the National Consumers League responded to the Request for Information regarding FDA-Regulation of CBD.

In 2019, in response to the proliferation of unreviewed and untested CBD products, NCL identified the need for greater education among consumers about CBD and better enforcement of regulations in the CBD marketplace. NCL created Consumers for Safe CBD to address the need, champion the rights of consumers, and call on government and industry to do better – to ensure safety and promote a pathway for new products through clinically tested scientific research. Since then, action has been taken on the state and federal levels to increase access to cannabinoids beyond CBD. In response, NCL expanded our educational campaign and established Cannabis Consumer Watch.” 

The full letter can be found here.

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About the National Consumers League (NCL)
The National Consumers League, founded in 1899, is America’s pioneer consumer organization.  Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad.  For more information, visit nclnet.org.

New insurance schemes to carve out specialty drugs deserve skepticism and scrutiny

Sally Greenberg

By Sally Greenberg, Chief Executive Officer

Employers seeking to cut healthcare costs should remember this simple rule of thumb: If an offer to save money seems too good to be true, it usually is. That seems to be the case with offers to try “Alternative Funding Programs” or AFPs.  This is a devious but growing cottage industry, which promises to cut employer costs for specialty medicines.

Specialty medicines are used to treat complex, chronic conditions like cancer and rheumatoid arthritis; they are drugs often offered to some of the sickest patients. While they represent a mere 2 percent of prescriptions, they add up to half of the estimated $500 billion spent each year in the U.S. on drugs. Thus, specialty drugs are hefty contributors to self-funded employers’ health plan costs. (Source: optum.com)

One “solution” offered by third party vendors peddling AFPs is to remove coverage of specialty drugs from the employer’s formulary. This immediately renders those employees “uninsured” as far as coverage for their needed drugs goes. The AFP vendor then matches the newly uninsured employee with a patient assistance program offered by drug manufacturers and other charitable foundations. The patient’s co-pay is fully covered by the assistance program, the employer saves money, and the vendor takes a cut of the savings.

We think this so-called solution is underhanded and dangerous for patients.  It is also unethical and possibly illegal.

First, the charitable programs being mined by the AFP vendors are meant for the truly needy—those who are uninsured or underinsured. If these sources of funding are being drained by the AFPs, they won’t be available for patients who really need the assistance.

These programs are having a predictable effect:  drug manufacturers are starting to tighten the eligibility criteria for their charitable programs, limiting them to patients who are truly uninsured. That means the AFPs won’t be able to fulfill their promise to find alternative sources to pay for the medicine. The inevitable will happen:  patients will be forced to go back to their employers’ insurance, causing dangerous delays in treatment and eliminating any savings.

Critically, the AFP process interrupts and delays care for patients. One of the AFP vendors, aptly named SHARx, with a logo shaped like the predatory creature its name invokes, admits the process can take 2 to 6 weeks. While trying to enroll the previously insured patient in an assistance plan, they’ll “do as much as they can” to help a patient access their medicine, sometimes demanding they sign over power-of-attorney to their company. In practice, that means patients can be left in limbo with no coverage for a period of time.

How can an employer ethically expose their employees with serious health conditions to that risk? (Source: sharxplan.com)

There are also ERISA and IRS legal and compliance risks to self-insured employers, too, according to an analysis by Vivio, a Public Benefits Corporation (Source: viviohealth.com)

And by some accounts, the AFP vendors are taking a huge cut of any savings, as much as 25 percent, on top of the administrative costs employers must pay to implement the program. (Source: drugchannels.net)

Nonetheless, according to a 2022 survey, 10 percent of self-insured employers with at least 5,000 U.S. employees are using alternative funding vendors. Some 8 percent said they were planning to use them within two years and 19 percent are considering their use in three to five years. (Source: optum.com)

It is easy to initially discount AFP critics as defenders of unfettered drug pricing. However, even Optum, a subsidiary of leading health plan provider United Health Care, has sounded the alarm. They advise their clients “to look past the short-term sales pitch and consider longer-term financial implications, compliance risk and ethics of alternative funding programs.” (Source: optum.com)

We are raising the voice of consumers in support of efforts in Congress to rein in other dubious co-pay assistance schemes deployed by Pharmacy Benefit Managers such as co-pay maximizers and accumulators.  In this case, employers should take the lead in standing up for their employees’ health by refusing to open the door when third party AFP vendors come calling.

Safety in question: The alarming disparities between cannabis product health claims and research, and the magnified risks for women

By Health Policy Intern Grace Lassila

July 27, 2023

When I started my National Consumers League (NCL) internship in May 2023, I quickly dove into NCL’s health policy work. NCL is leading on several efforts to protect consumers –one area of focus that stood out to me is their work in the cannabis policy space. NCL is a founding member of Cannabis Consumer Watch (CCW), which educates consumers on cannabinoids, their effects, the risks related to the unregulated marketplace, and the ways policymakers and regulators can help protect consumers. NCL is also a part of the Collaborative for Cannabinoid Science and Safety (CCSS), which also works to educate people about cannabinoids and policy in the interest of public health.

CCW’s “test your cannabis knowledge” quiz was shocking for me. Going into the quiz, I was fairly confident about my knowledge, but as I started getting wrong answer after wrong answer, I realized I had no idea that not only are these products under-researched, but they may pose serious public health risks for consumers. Products can be sold, without having gained FDA approval, making false claims about their medicinal abilities.  And side effects are not adequately researched or revealed to consumers.

One particularly concerning aspect of the cannabis marketplace is that while CBD or Delta-8 or other cannabis products are often marketed to women, there is a concerning lack of research into the safety of these products for women. Historically, misogyny and sex discrimination have made women’s health severely under-researched and underfunded. More research on diseases, disorders, and medication is conducted on men, not women. Women are misdiagnosed far greater than men are, and experience dangerous health outcomes because of it (Greenhalgh). And without sufficient research and data on women’s health, it is incredibly difficult for legislators to write policy (Adams). Overall, for women’s health to improve, more resources need to be devoted to this issue.

Despite cannabis companies’ marketing efforts that claim their products can help with anything from menstrual cycle-related pain to morning sickness, there is little insight into the effects of cannabis or cannabis derivatives on women, pregnant people, nursing parents, and newborns. What we do know is that the risks are very real – a recent study found that THC use during pregnancy was linked to changes in fetal development and several studies have shown that CBD can be transferred to a baby via breast milk. The FDA strongly advises against THC or CBD usage while pregnant or breastfeeding. And, given the evidence currently available, I would caution any women from using these products for medical benefit.

The lack of regulation, as well as research, is very concerning. Because the FDA currently does not regulate these products, consumers have no way of knowing whether the dosage, ingredients, or claims on the label are accurate and no way of knowing whether or not they are contaminated. Though some products may acknowledge they are ‘Not Approved by FDA,’ many consumers may not see this fine print – and assume that anything they can buy at their local grocery store must be safe for consumption. While the risks of an unregulated cannabis marketplace affects all consumers, women who need medical health and relief and turn to cannabis products may be more at risk.

The good news is that in January of this year, the FDA recognized this grey area for regulation – particularly for CBD – and stated that CBD would not be regulated as a food and dietary supplement anymore, because of the unknown safety risks, and requesting that Congress act quickly to protect public health and the consumers involved.

While cannabis products are often marketed as a miracle drug, they are not. While there may be some health benefits, without comprehensive research and regulation of these products, the risks outweigh the potential good. Consumers remain responsible for making their health decisions, and women in particular should be vigilant. The FDA is heading in the right direction but more must be done to protect consumers – and women in particular. I encourage you to learn more about a safe path forward here and help NCL raise awareness of this important issue.

Sources:

Adams, Katie. “Women’s Health Is Suffering Due to Lack of Research and Funding, Experts Say.” MedCity News, 9 Dec. 2022, medcitynews.com/2022/12/womens-health-is-suffering-due-to-lack-of-research-and-funding-experts-say/#:~:text=Women’s%20health%20has%20been%20historically,healthcare%20conference%20in%20Washington%2C%20D.C.

Eversheds Sutherland. “FDA Says ‘No’ to CBD: Now What?” FDA Says “No” to CBD: Now What? – Eversheds Sutherland, us.eversheds-sutherland.com/mobile/NewsCommentary/Legal-Alerts/256713/FDA-says-no-to-CBD-Now-what#:~:text=Since%202018%2C%20the%20FDA%20has,%2Dapproved%20drug%20(Epidiolex). Accessed 6 July 2023.

Greenhalgh, Ally. “Medicine and Misogyny: The Misdiagnosis of Women.” Confluence, 5 Dec. 2022, confluence.gallatin.nyu.edu/sections/research/medicine-and-misogyny-the-misdiagnosis-of-women.

Grinspoon, Peter. “Cannabidiol (CBD): What We Know and What We Don’t.” Harvard Health, 24 Sept. 2021, www.health.harvard.edu/blog/cannabidiol-cbd-what-we-know-and-what-we-dont-2018082414476.

“What You Should Know about Using CBD When Pregnant or Breastfeeding.” U.S. Food and Drug Administration, www.fda.gov/consumers/consumer-updates/what-you-should-know-about-using-cannabis-including-cbd-when-pregnant-or-breastfeeding#:~:text=FDA%20strongly%20advises%20against%20the,during%20pregnancy%20or%20while%20breastfeeding.&text=Cannabis%20and%20Cannabis-derived%20products,products%20appearing%20all%20the%20time. Accessed 6 July 2023.

NCL applauds the FDA for renewing its focus on infant formula

July 14, 2022

Media contact: National Consumers League – Katie Brown, katie@nclnet.org, (202) 207-2832

Washington, DC— The National Consumers League (NCL) applauds the Food and Drug Administration (FDA) for taking strong steps to assure consumers that infant formula coming from overseas has been properly inspected and is free from contaminants or adulterants and therefore safe for infants.

“Consumers should have confidence that the infant formula that is being imported to the U.S. … involved a thorough review of the information provided by the companies, including details about the product’s nutritional adequacy and safety, microbiological testing results, labeling information, and importantly, details about the manufacturing facility’s food safety production practices and inspection history,” according to a press statement posted on FDA.gov.

Over the past few months NCL, the nation’s oldest consumer advocacy organization, has issued several statements on the infant formula shortage. The shortage was caused primarily by the unconscionable and unsanitary practices at Abbott’s Michigan infant formula facility when it failed to follow safety protocols, falsified documents to the FDA, and then shipped contaminated formula resulting in babies contracting foodborne illnesses and as many as nine infant deaths, according to FDA documents. Abbott’s reckless actions – coupled with the FDA’s slow response to the outbreak – finally lead to both parties issuing a recall of the faulty formula and ultimately triggered a nationwide shortage of powdered infant formula.

As FDA renews its focus on infant formula, NCL applauds the agency’s determined outreach to keep parents informed about how to read food labels from products made abroad. These labels use metric measurements that consumers in the United States may not easily comprehend. Most importantly, FDA has ramped up inspections of the products to ensure good and safe manufacturing processes.

Below are several statements on the infant formula crisis issued by NCL in the past few months, one of which includes our June 16 testimony before a Senate Judiciary Subcommittee.

https://nclnet.org/ncl-applauds-fda-response-formula-shortage/

https://nclnet.org/senate-testimony-consolidation-harms-consumers/

https://nclnet.org/baby-formula-shortage/

 

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About the National Consumers League (NCL) 

The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.

NCL denounces today’s SCOTUS ruling overturning Roe v. Wade

June 24, 2022

Media contact: National Consumers League – Melody Merin, melodym@nclnet.org, (202) 207-2831

Washington, DC— Almost 50 years since the Supreme Court ruling in 1973, Roe v. Wade, which guaranteed a woman’s constitutional right to an abortion, the protections provided by Roe were overturned today by the Supreme Court of the United States (SCOTUS). The ruling is a devastating blow to women, girls, and their families who have long fought for equal access to reproductive health services – health services which includes access to safe abortion, says the National Consumers League (NCL).

“Many women will suffer and will suffer unnecessarily from this egregious ruling by SCOTUS,” says Sally Greenberg, Executive Director of NCL. “This decision is an attack on poor women or low-income woman, who represent 75% of abortion patients,” according to the Guttmacher Institute, a research group that supports abortion rights.

The final opinion is strikingly similar to the draft that was leaked in May of this year and authored by Justice Samuel Alito. In the opinion, Alito writes, “It is time to heed the Constitution and return the issue of abortion to the people’s elected representatives.”

In the wake of this June 24 ruling, 26 states are expected to ban all or nearly all abortions.

Justice Clarence Thomas, in his concurring opinion overturning Roe v. Wade, laid out a vision that fomented fears about what other rights could disappear: the same rationale that the Supreme Court used to declare there was no right to abortion, he said, should also be used to overturn cases establishing rights to contraception, same-sex consensual relations and same-sex marriage.

In their joint dissent, the three liberal justices of the court, argued that the ruling will affect “countless life decisions.” They also noted that, “It says that from the very moment of fertilization, a woman has no rights to speak of.”

“NCL applauds responses from many employers, including JPMorgan Chase, which is clarifying its health care benefits in the wake of the Supreme Court overturning Roe v. Wade on Friday, saying that abortion has long been a covered service for the bank and starting in July will be included under the company’s health care travel benefit,” says Greenberg. “We applaud Levi Strauss & Co — the 169-year-old jean company — stands strongly against restricting access to abortion and said it will continue to protect employees — making sure they have access to the care they need regardless of where they live.

NCL also thanks officials in many states and the District of Columbia that have pledged to provide abortion access and safe havens including New Hampshire, Michigan, New York governors along with New York Attorney General Letitia James and DC Mayor Muriel Bowser.

In his address to the nation today, President Joe Biden expressed his disappointment over the SCOTUS ruling: “This is a sad day for the country in my view, but it doesn’t mean the fight is over.” He also added that his administration will use all its appropriate lawful powers and that “Congress must act.” He went on to say, “with your vote, you can act.”

NCL believes that women’s reproductive rights is fundamental and must be protected; this radical decision by the Supreme Court is vastly out of step with American public opinion and a disastrous for women’s rights and freedoms.  We will continue to advocate for federal, state and local protections for women across the country, in keeping with NCL’s long history of championing the rights of women and children, especially those among us who are most vulnerable.

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About the National Consumers League (NCL) 

The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.

The failure of the AHCA is a victory for the American people – National Consumers League

j_johnson92.jpgSpotlight on Health Care Series, Part 2: As America’s health care system is facing uncertainty, NCL staff is exploring the topic in a new weekly blog series.

Ding dong, the bill is dead! Democrats, health advocates, patients, and consumers across the country are rejoicing after the GOP’s first attempt to repeal and replace major pieces of the Affordable Care Act (ACA) crashed and burned. Republicans ultimately could not coalesce around House Speaker Paul Ryan’s (R-WI) American Health Care Act (AHCA) and, in a stunning turn of events, the bill was pulled from the House floor without a vote last Friday.While inability to build a solid block of support for the AHCA in Congress became painfully obvious over time, the American people made their disdain of the bill apparent from the start. In the weeks following its introduction, citizens from every corner of the nation fervently expressed their disgust with the attack being waged on their health care. By the time the would-be vote was to have taken place, the AHCA had a meager 17 percent public approval rating, according to a Quinnipiac poll. Though dismal, this figure is hardly surprising, as the bill did nothing to improve access to care or quality of coverage for a clear majority of Americans – and, in many cases, the bill would have left many worse off than before the ACA.

The AHCA touted several policy changes that would have undoubtedly wreaked havoc on our health care system. Paramount was the spending cap (read: MASSIVE CUT) on Medicaid, the defunding of Planned Parenthood, an exponential premium increase for older Americans, a cost shift from the federal government to states and their citizens, and a general rationing and reduction of care to cover massive tax cuts for the wealthy. Arguably, one of the bill’s most odious aspects was the elimination of the essential health benefits – a measure put on the table in a last-ditch effort to get the unyielding, far-right, so-called “Freedom Caucus” block of the House on board. The essential health benefits are 10 services the ACA requires all plans to cover, including maternity and newborn care, ambulatory services, preventive and wellness services, and substance use treatment that can address issues such as the opioid epidemic ravaging communities across the country. Women of child-bearing age would have experienced significantly higher health care costs due to the elimination of maternity care and contraception from the standard benefits package – and they would either have considerably higher premiums than their male counterparts or be forced to pay for their maternity care or contraceptive methods out-of-pocket.

In addition, the AHCA would have effectively gutted consumer health protections, particularly for patients with pre-existing conditions, by eliminating out-of-pocket caps and reinstating lifetime coverage limits. In the long run, adequate care would be far beyond the reach of many Americans who would be left with bare-bones coverage and a higher cost burden. What is worse, by 2026, 24 million Americans would lose their coverage altogether. Americans heard that message loud and clear and they didn’t like what they heard.

While we can breathe a sigh of relief that the ACA is still the law of the land, NCL is among the many groups that agree that the ACA needs some tweaks to make it work better for all Americans. Now more than ever, a bipartisan approach to bringing affordable care and coverage to ALL Americans is not only desired, but essential. Rather than trying to undermine the ACA, Republicans and Democrats should embrace this opportunity to work together to come up with solutions that address the current insufficiencies in health care and make our system one that works for everyone.

The defeat of the AHCA is a big victory for the American people. The persistence and hard work of everyday Americans who spoke up, who called their members of Congress, who attended rallies, wrote to their local papers, and used social media ultimately made the difference. The National Consumers League, which since our inception in 1899 has spoken up for consumers and supported health insurance for all Americans, is proud to have stood alongside our colleagues in the consumer and public health communities in this battle to defend our care and oppose policies that would send us backward. We will continue to fight to protect the ACA, preserve consumer health protections, and argue that it is good for the economy and good for America’s future if all of us have access to health care coverage.