Monday, September 25, 2023

Prescribing food as medicine lowers weight, blood pressure, and blood sugar

At the health system where I work, I can refer patients with food insecurity and chronic health conditions that are sensitive to diet quality to a “Food Farmacy” to meet with dietitians and receive free produce from local food pantries. Similar “food as medicine” programs have been piloted throughout the United States, including several led by family medicine residencies. As Dr. Jen Middleton wrote on the American Family Physician Community Blog, the 2022 White House Conference on Hunger, Nutrition and Health made a number of policy recommendations to improve the accessibility of nutritious foods, including “accelerat[ing] access to ‘Food Is Medicine’ services to prevent and treat diet-related illness.” However, research on the health outcomes of such programs has been limited.

In a recent study published in Circulation: Cardiovascular Quality and Outcomes, researchers evaluated the impact of produce prescriptions on food insecurity and health status in nearly 4000 adults and children at 22 sites located in 12 states. 63 percent of households were enrolled in the Supplemental Nutrition Assistance Program (SNAP), and 83 percent were enrolled in the Special Supplemental Nutritional Program for Women, Infants, and Children (WIC). Clinicians referred patients for enrollment in nutrition classes, and individuals or households received paper vouchers or electronic cards averaging $63 per person per month to purchase fruits and vegetables from participating grocery stores and farmer’s markets. Program durations varied from 4 to 10 months.

Compared to pre-program enrollment, the daily fruit and vegetable intake of adults and children increased by 0.85 and 0.26 cups, respectively. Produce prescriptions were associated with decreased food insecurity (odds ratio, 0.63) and improvements in self-reported health status in 85 percent of patients. Adults with diabetes saw their absolute hemoglobin A1c levels drop by 0.29 percent, and adults with overweight or obesity had average decreases in body mass index of 0.36 kg/meters squared. Adults with hypertension had lower systolic and diastolic blood pressures of 8.4 mm Hg and 4.9 mm Hg, respectively, at the end of the program.

Although health insurers have not historically paid for patients to fill healthy food prescriptions, a few Medicare Advantage and Medicaid programs now cover produce purchases and other nutrition-focused interventions in high-risk patients. In addition to health gains, the economic case for expanding and sustaining these programs in the long term is strong. A microsimulation modeling study projected that over a lifetime,

implementing produce prescriptions in 6.5 million US adults with both diabetes and food insecurity would prevent 292 000 (95% uncertainty interval, 143 000–440 000) cardiovascular disease events, generate 260 000 (110000–411 000) quality‐adjusted life‐years, cost $44.3 billion in implementation costs, and save $39.6 billion ($20.5–58.6 billion) in health care costs and $4.8 billion ($1.84–$7.70 billion) in productivity costs. The program was highly cost effective from a health care perspective (incremental cost‐effectiveness ratio: $18 100/quality‐adjusted life‐years) and cost saving from a societal perspective (net savings: $−0.05 billion).

A 2018 AFP editorial provided other practical information for clinicians to help patients with food insecurity, including a list of food assistance programs for children and adults.


This post first appeared on the AFP Community Blog.

Wednesday, September 13, 2023

CMS announces “top 10” costly drugs list selected for price negotiations

Two weeks ago, the Centers for Medicare & Medicaid Services (CMS) announced the first 10 brand name medications that it will negotiate Medicare Part D prices directly with drug manufacturers to take effect starting in 2026. Several of these medications are commonly prescribed by primary care physicians and were discussed in American Family Physician’s STEPS (Safety, Tolerability, Efficacy, Price, Simplicity) New Drug Reviews feature from 2007 to 2020. Each drug received U.S. Food and Drug Administration (FDA) approval for at least one indication before September 2016 and currently faces no generic competition.

Apixaban (Eliquis)

Empagliflozin (Jardiance)

Rivaroxaban (Xarelto)

Sitagliptin (Januvia)

Dapagliflozin (Farxiga)

Sacubitril/valsartan (Entresto)

Etanercept (Enbrel)

Ibrutinib (Imbruvica)

Ustekinumab (Stelara)

Insulin aspart (Novolog/Fiasp)

Although Medicare began paying for prescription drugs in 2006, the legislation that created the Part D drug benefit prohibited the federal government from using its purchasing power to negotiate prices directly with pharmaceutical companies, as most government health programs in other countries do from the time of market entry. This changed with the passage of the Inflation Reduction Act in August 2022, which not only gave CMS the authority to negotiate prices of selected brand-name drugs, but also penalizes companies that increase prices faster than inflation and caps Medicare beneficiaries’ annual out-of-pocket drug spending starting in 2024.

Manufacturers have until October 1, 2023 to decide if they will participate in negotiations with CMS to establish a “maximum fair price” for the designated drugs in Medicare Part D or accept financial penalties for not doing so. Negotiations that will take place over the next year will ultimately establish a discounted price that is at least 25 to 60% lower than the drug’s list price. Collectively, the federal government is expected to save $100 billion over the next decade. That’s because a small number of brand-name drugs have an outsized budget impact, with the 10 most expensive drugs accounting for 22 percent of gross Medicare Part D spending in 2021. In addition, there may be “spillover” effects from negotiated lower prices because competitors in the same therapeutic class may decide to lower their prices or risk being left off of Part D drug formularies.

Given potentially large financial impacts on the companies involved (Eliquis, Jardiance, and Enbrel comprise 23 to 33 percent of U.S. prescription drug sales of their respective manufacturers, according to STAT), the pharmaceutical industry has already filed multiple lawsuits seeking to stop price negotiations before they take effect in 2026. Although the industry warns that less revenue could discourage innovation and new drug development, the nonpartisan Congressional Budget Office has estimated that price negotiations would have a small impact on FDA new drug approvals, with 15 fewer drugs approved over the next 30 years out of about 1300 projected.


This post first appeared on the AFP Community Blog.

Sunday, August 27, 2023

For accurate blood pressure measurement, cuff size matters

A thought-provoking editorial in the August issue of American Family Physician discussed the reasons for the divergence in treatment guidelines for mild hypertension that followed the publication of the Systolic Blood Pressure Intervention Trial (SPRINT). Dr. Stephen Martin noted that “in SPRINT, blood pressure was measured using ideal techniques that are unlikely to be replicated using standard practice.” These blood pressure (BP) measurement practices, described in a 2018 editorial about the American College of Cardiology/American Heart Association (ACC/AHA) hypertension guideline and reiterated in a clinical review article on home BP monitoring, include using an appropriately sized blood pressure cuff:

To determine cuff size, patients should measure their arm circumference at the midpoint of the upper arm. The bladder length should be 75% to 100% of the arm circumference, and bladder width should be 37% to 50% of the arm circumference.

Four adult BP cuff sizes are available in the United States: small (20 to 25 cm mid-arm circumference), regular (25.1 to 32 cm), large (32.1 to 40 cm), and extra-large (40.1 to 55 cm). Although most primary care offices have cuffs in multiple sizes, home BP monitors sold in pharmacies typically use the regular cuff size, which is too small for many adults.

Just how inaccurate is an automated BP reading in an adult patient wearing a cuff that is too small or too large? To answer this question, researchers from Johns Hopkins University performed a randomized crossover trial in 195 community-dwelling adults. The mean age was 54 years, and about one-half had a BP higher than 130/80 mm Hg when using an appropriately sized cuff. Researchers determined that a regular size cuff was appropriate for 54 study participants, whereas 35 required a small cuff and 106 required a large or extra-large size.

Each participant had four sets of triplicate BP measurements, using a cuff size that was appropriate, too small, or too arge in random order, followed by an appropriately sized cuff. Participants for whom a large or extra-large cuff size was appropriate had their systolic BPs overestimated by about 5 and 20 mm Hg, respectively, when using a regular size cuff. Diastolic BP overestimations were smaller but still statistically significant (1.8 and 7.4 mm Hg). Conversely, participants for whom a small cuff size was appropriate had their systolic BP underestimated by 3.6 mm Hg when wearing a regular size cuff. A recent analysis found that more than half of U.S. adults need a large or extra-large size, and the study authors noted the immense global implications of using cuffs that are too small:

In this context, 40% or more U.S. consumers would obtain BP readings overestimated by almost 5 mm Hg when conducting home BP monitoring. On a global scale, an error in SBP measurement of 5 mm Hg could lead to the misclassification of 84 million people to either undertreatment or overtreatment of hypertension.

In a table summarizing lessons learned and cautions raised by SPRINT, Dr. Martin warned, “Prevention and associated overdiagnosis can divert our attention from sick patients to healthy patients.” Whether family physicians and their patients are aiming for the ACC/AHA guideline’s lower BP targets or the 140/90 mm Hg target recommended for most people by the American Academy of Family Physicians, using an appropriately sized cuff is critical to avoid overdiagnosing healthy adults with hypertension.


This post first appeared on the AFP Community Blog.

Sunday, August 20, 2023

Preventing Overdiagnosis: do Americans have too many cancer screening choices?

At the Preventing Overdiagnosis Conference in Copenhagen last week, I joined nearly four hundred like-minded family and subspecialist physicians, health professionals, and researchers who are concerned about reducing the harms to patients of widening disease definitions and resulting overdiagnosis and overtreatment. After the American Board of Internal Medicine Foundation's discontinuation of logistical support for the Choosing Wisely campaign and the retirement of JAMA Internal Medicine editor and "Less Is More" champion Rita Redberg (who also attended the conference), it was reassuring to hear that the vital work of doing less to patients and more for them will go on. In addition, the international composition of conference attendees allowed me to learn more about different medical practices in Europe and around the world. Although overuse isn't the only reason that the U.S. spends by far the most per capita of any nation on health care, it does play an important role.

In Germany, where family doctors have an average of just 9 minutes (!) per patient consultation, the German College of General Practice and Family Medicine nonetheless found time to develop a prioritized guideline on “Protection against the overuse and underuse of health care.” Although we have a little more time per patient in the U.S., much of this extra time is spent administering standardized questionnaires to screen for depression and anxiety, a practice that doesn't occur in Canada or the United Kingdom and may, despite the U.S. Preventive Service's Task Force (USPSTF)'s endorsement, lead to more harm (opportunity costs and overdiagnosis) than good.

Another area where the U.S. and Canada differ is screening for osteoporosis in primary care. While the USPSTF recommends that all women aged 65 years and older undergo bone measurement testing for osteoporosis (a disease-oriented outcome), the Canadian Task Force on Preventive Health Care recommends “risk assessment–first” screening for prevention of fragility fractures (a patient-oriented outcome) in the same age group, and recommends against screening younger women or men at any age. Not only is the Canadian approach more efficient than universal screening, Roland Grad and colleagues have determined that it requires less clinician time. When there isn't nearly enough time for prevention in primary care, argued Sweden's Minna Johansson and the Mayo Clinic's Victor Montori, guidelines should consider clinicians' time needed to treat.

How much time do Danish general practitioners spend discussing various colorectal cancer screening options? None! In the U.S., a substantial part of every health maintenance visit with a patient aged 50 years (or, perhaps, 45) or older is devoted to having an individual shared decision making discussion about the pros and cons of fecal immunochemical testing (FIT), fecal DNA and FIT co-testing, and screening colonoscopy, then either ordering their preferred test or documenting that they declined to be screened. In Denmark, the public health system identifies age-eligible patients and sends them a FIT test in the mail every 2 years. As a result, the COVID-19 pandemic had only modest effects on Danish adults' participation in colorectal screening and adherence to colonoscopy following a positive test. In the U.S., many practices and health systems are still catching up on the backlog.

Although Americans supposedly value choice in health care, our non-system restricts choice at every turn, through narrow preferred provider networks, limited drug formularies, and the bane of every U.S. family physician's existence: prior authorization. Sometimes it seems that the only area where my patients have choices is cancer screening; male patients of a certain age can even choose to have a PSA test, even though most of the world has rightly concluded that the harms of prostate cancer screening outweigh any benefits. And look out for the multicancer early detection blood tests in development; even though these tests have no proven health benefits and will almost certainly increase false positives and overdiagnosis, no doubt Americans will be among the first to embrace them. There is such a thing as having too many cancer screening choices, if most of them are bad.

Monday, August 14, 2023

Get out the vote: supporting civic health in primary care

The national organization Vot-ER has designated August as Civic Health Month, “a time to showcase the link between voting and health and celebrate efforts that ensure each and every voter has the opportunity to support their community’s health at the ballot box.” Partners, including the Association of American Medical Colleges, encourage clinicians and health care organizations to support an inclusive democracy by providing patients with nonpartisan education and voter registration services.

recent narrative review in The Milbank Quarterly explored the role of primary care in advancing civic engagement and health equity. Research shows that poorer population health is associated with lower voter turnout, with stronger associations occurring in early adulthood rather than in middle age. On the other hand, voting is associated with positive mental health and health behaviors, and higher levels of individual happiness strongly predict future civic engagement. Similarly, volunteers are less likely to be hospitalized and more likely to receive preventive care, even after controlling for age, gender, race, income, education, and insurance status: “In one study of US adults, volunteers spent 38% fewer nights in a hospital and were more likely to receive services such as flu shots, cholesterol screening, mammograms, and prostate exams as compared with nonvolunteers.”

Primary care physicians have successfully engaged patients with “civic health check-ups” at federally qualified health centers and other outpatient locations. In a voter registration project in the waiting areas of two family medicine residency clinics in the Bronx, volunteers registered 114 of 128 eligible patients during a 12-week period, 65% of whom were younger than 40 years. During the COVID-19 pandemic, a general internal medicine clinic in North Carolina used its patient portal to disseminate a REDCap survey containing embedded links to voter resources, including safer alternatives to in-person voting during the 2020 elections.

Outside of these and other individual case studies, voter enfranchisement remains, to borrow from the title of a 2020 perspective article in the Journal of General Internal Medicine, “an underused treatment strategy." To make voting a “standard of care,” Vot-ER and its partners are hosting several online events this month for clinicians who are interested in empowering patients to support their community’s health at the ballot box.


This post first appeared on the AFP Community Blog.

Tuesday, August 1, 2023

Current prescriptions for addressing health-related social needs fall short

According to one recent estimate, cumulative poverty (earning less than 50% of median household income in at least one of the past 10 years) and current poverty are the fourth and seventh leading causes of death in the United States, respectively, on par with obesity and dementia and behind only heart disease, cancer, and tobacco use. The knowledge that financial insecurity and resulting social needs have profound effects on health has inspired organized medicine initiatives aimed at identifying and meeting those needs, such as the American Academy of Family Physicians’ (AAFP) The EveryONE Project.

In a 2019 editorial, Dr. Kevin Sherin and colleagues asserted that “family physicians have a leadership role in identifying and addressing issues that affect patients beyond the clinical setting.” They highlighted the AAFP’s Neighborhood Navigator tool (formerly Aunt Bertha/findhelp), which clinicians and primary care teams can use to link patients to available community resources for different types of social needs. A recent Graham Center Policy One-Pager found that the most common Neighborhood Navigator searches since 2018 were for food, housing, and health care.

Some practices and health care systems have begun screening patients for social needs using print or electronic health record-embedded questionnaires. Two articles in FPM (A Practical Approach by Drs. David O’Gurek and Carla Henke and Screening in Daily Practice by Dr. Vinita Magoon) reviewed the logistics of designing a practice workflow for screening and coding and payment considerations. Gaps in the evidence regarding the effectiveness of screening remain, however. Although the U.S. Preventive Services Task Force considers social risk in the majority of its recommendation statements, it has not found sufficient evidence to recommend screening for social needs. In a 2019 editorial, Dr. Alex Krist and colleagues discussed the research that still needs to be performed:

These recommendations highlight what is needed before recommending routine screening for social needs: an accurate screening test to identify patients with the social need, an effective treatment to address the social need once identified, and evidence demonstrating a meaningful health outcome improvement for patients.

In 2017, the Centers for Medicare and Medicaid Innovation launched the Accountable Health Communities Model, a five-year demonstration project that evaluated whether a proactive approach to identifying and addressing patients’ health-related social needs could reduce care utilization and spending. Although primary care referrals to community services increased for eligible patients, an independent evaluation found that they were no more likely to utilize these services or have their needs met than patients in a randomized control group. Patients often had a hard time reaching community service providers, were deemed ineligible for their services, or did not receive sufficient help from the provider to resolve their need (e.g., continued to have food insecurity despite receiving food assistance). A Health Affairs Forefront commentary pointed out the need to solve the “last mile problem”:

Even when patients received navigation and social service providers had capacity, gaining access to timely social services required some combination of hours of free time to make phone calls, important paperwork at one’s fingertips to apply, and a PhD in social work to understand eligibility rules.… Meaningful navigation support must … not only connect patients to appropriate services, but to ensure the patient’s social needs are met.

Equally important, many community organizations have inadequate resources and funding to serve their populations. A microsimulation study in JAMA Internal Medicine estimated the costs of implementing interventions to address social needs identified in primary care practices. Existing federal funding mechanisms (e.g., the Supplemental Nutritional Assistance Program) covered less than half of the cost of providing food, housing, transportation, and care coordination support for patients with at least one of these four needs. Clearly, the health care system cannot address health-related social needs on its own. As the unwinding of Medicaid’s COVID-19 continuous enrollment condition (which expired on March 31, 2023) proceeds, the need for social policy as health policy has never been greater.


This post first appeared on the AFP Community Blog.