What's the matter with corporate primary care?

I've been meaning to write about this topic for a while, but Dr. Josh Freeman at Medicine and Social Justice beat me to it last week. Josh is a fellow blogger, retired family physician, and Chair emeritus of the Department of Family Medicine at the University of Kansas. His latest post, "Private equity, private profit, Medicare and your health: They are incompatible," explored in depth the negative effects of private equity and for-profit corporations buying up subspecialty and primary care practices, also discussed in a KFF Health News article and in the New York Times. Put simply, the goal of those purchases is to turn a quick profit - often by "upcoding" to charge more for visits and procedures and slashing critical support staff - rather than to serve the best interests of patients and clinicians. Part of the corporate rush to invest aggressively in primary care is the unintended consequence of privatizing Medicare and moving away from the fee-for-service payment model; private health insurers now receive a lump sum "value based care" payment for every enrolled Medicare beneficiary based on their medical complexity and health risks, a process that Paul Branstad and Claude Maechling observed can easily be gamed:

Value-based contracts with full-risk capitation payments, mostly Medicare Advantage (MA), but also variants of accountable care organization (ACO) models, have grown rapidly to become the majority payment model for Medicare beneficiaries. However, there is no demonstrated proof that these payment arrangements improve the health of beneficiaries more than fee-for-service arrangements. We also fear that, in their current forms, such contracts reward ever-increasing scale and will evolve into a competition that only the very largest consumer companies can win. Once these winners emerge, their vested interests will focus on preserving their oligopoly at an additional cost to US taxpayers of $75 billion a year. Too late will we realize we have lost our last best chance to reinvent a health care system centered around the large-scale provision of high-quality primary care—even though this is what value-based contracts started out trying to do.

Another reason that retail giants such as Amazon and CVS Health have recently invested billions of dollars in primary care companies (One Medical and Oak Street Health) is that they anticipate steering thousands of patients to their pharmacy and disease management products. CVS Health's CEO is confidently projecting that investors will realize "double-digit returns on invested capital over time as clinics mature and synergies are realized."

Although private investment has infiltrated nearly every sector of health care, including oncology clinics, neonatology practices, and the gastroenterology practice where I refer most of my patients for procedures or challenging gastrointestinal problems, the profit motive may do the most damage in primary care, which improves population health when it is treated as a common good rather than as a loss leader for more profitable procedural subspecialties and hospital-based services. As Soleil Shah and colleagues wrote in the New England Journal of Medicine: "Though potentially beneficial for certain well-insured patients, the trend of corporate investment in primary care could threaten equitable access to care, raise health care costs, and reduce physicians’ clinical autonomy."

Sounding the alarm about the "existential threat of greed" in a JAMA Viewpoint and his Institute for Healthcare Improvement 2022 National Forum keynote address, Don Berwick made these stark observations about the wrong direction that the excessive pursuit of financial profit has been taking the U.S. health care system, and now corporate primary care:

Profit may have its place in motivating innovation and higher quality in health care, as in any industry. But kleptocapitalist behaviors that raise prices, salaries, market power, and government payment to extreme levels hurt patients and families, vulnerable institutions, governmental programs, small and large businesses, and workforce morale. Those behaviors, mostly legal but nonetheless wrong, have now accumulated to a level that poses an existential threat to a sustainable, equitable, and compassionate health care system. ... US health care costs nearly twice as much as care in any other developed nation, whereas US health status, equity, and longevity lag far behind. Unchecked greed is not the only driver of that failure, but it is a major one. Few, if any, other developed nations tolerate the levels of avarice, manipulation, and profiteering in health care that the US does. Salve lucrum [Hail, Profit!] is the wrong answer.

Photo courtesy of Pompeii in Pictures https://www.pompeiiinpictures.com/pompeiiinpictures/R7/7%2001%2047.htm

Updated immunization and screening recommendations aim to eradicate hepatitis B

In November 2021, the Centers for Disease Control and Prevention (CDC)’s Advisory Committee on Immunization Practices (ACIP) replaced risk factor-based eligibility in adults with a recommendation for universal hepatitis B vaccination in persons aged 19 to 59 years. The ACIP noted that despite routine administration of hepatitis B vaccine in infancy, as of 2018 only 30% of U.S. adults had received the full vaccine series, and one half of acute hepatitis B cases occurred in persons aged 30 to 49 years. A national survey of family physicians in February 2022 found that more than half of respondents were not aware of the updated guidelines, and only 8% had fully implemented them.

Gaps in screening and treatment also put patients at greater risk of developing chronic hepatitis B and its complications. An analysis of insurance claims data from 2015 to 2020 found that even though all pregnant patients should be screened for hepatitis B at their first prenatal visit to prevent perinatal transmission, 14.6% did not have hepatitis B surface antigen (HBsAg) testing, representing as many as half a million births each year. Another study found that between 2016 and 2019, less than 30% of persons with chronic hepatitis B and cirrhosis started antiviral therapy within 12 months of diagnosis.

Since access to hepatologists is a barrier to patients with hepatitis B receiving appropriate management, a previous AFP Community Blog post described a practice model for family doctors to evaluate and treat these patients “in-house.” However, the complexity of screening and management guidelines has led to calls for a simplified approach to hepatitis B. In response, the CDC recently recommended that adults aged 18 years and older be tested for hepatitis B at least once during their lifetimes, regardless of prior immunizations or risk factors, mirroring the universal screening approach to hepatitis C and HIV. (Notably, the U.S. Preventive Services Task Force currently recommends a risk-based screening strategy in adolescents and adults.) To facilitate interpretation, screening should include HBsAg, antibody to HBsAg, and antibody to hepatitis B core antigen.

In a JAMA Viewpoint, Dr. Samuel So and colleagues asserted that as two-thirds of non-institutionalized persons with chronic hepatitis B are unaware of their infection, universal screening and vaccination of adults “are a major step forward to reducing chronic hepatitis B-related morbidity and mortality in the U.S.” Another commentary emphasized focusing on health equity in the national push to eradicate hepatitis B and hepatitis C, which is the target of a recently proposed national initiative. A white paper that I co-authored for the Hepatitis B Foundation presented challenges to implementing the updated CDC recommendations, best practices in primary care and hospital settings, and priority action items involving education, multi-stakeholder collaborations and technology innovations, and addressing vaccine hesitancy.

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This post first appeared on the AFP Community Blog.

Have pharmaceutical conflicts of interest unduly influenced asthma guidelines?

The single maintenance and reliever therapy (SMART) treatment approach to patients with asthma, outlined in the article on chronic asthma treatment in the April issue of American Family Physician, has consistent supporting evidence from multiple randomized controlled trials. A practical guide to implementing SMART has been widely disseminated to clinicians. However, an editorial by Dr. Steve Brown cautioned that SMART, which is strongly recommended in the 2022 GINA guidelines, has been “heavily influenced by the pharmaceutical industry,” namely AstraZeneca, which markets budesonide/fomoterol (Symbicort), the combination inhaler primarily studied in the trials:

The GINA board of directors and scientific committee members have substantial financial conflicts of interest. Twelve of 17 members, including both chairs, have received personal fees from AstraZeneca. … A 2018 systematic review of SMART for persistent asthma found 16 RCTs, and 15 of those evaluated SMART as a combination therapy with budesonide and formoterol in a dry-powder inhaler. Fourteen of the 15 studies were funded by AstraZeneca, had an AstraZeneca employee as a coauthor, or had authors who received honoraria or fees from Astra-Zeneca.

Why is it problematic that clinical trial investigators and GINA guideline panelists have numerous industry ties? A 2017 Cochrane review concluded that “sponsorship of drug and device studies by the manufacturing company leads to more favorable efficacy results and conclusions than sponsorship by other sources,” an inherent industry bias that “cannot be explained by standard ‘risk of bias’ assessments.” A 2020 systematic review found that guidelines with panelists with financial conflicts of interest were 26% more likely to favorably recommend a therapy than those without such conflicts.

In comparison to GINA, the less-conflicted panelists of the National Asthma Education and Prevention Program (NAEPP) focused guideline update, discussed in a previous AFP editorial, made a narrower “conditional” recommendation for SMART in patients age 12 years or older with moderate to severe persistent asthma.

Although some think that public disclosure of conflicts of interest can prevent or mitigate bias in clinical recommendations, Dr. Jay Siwek, my longtime mentor and editor-in-chief emeritus of AFP, has previously argued regarding clinical review articles and editorials that disclosure of conflicts is not enough. Note: I do not have any conflicts of interest related to the topic of this blog post.

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This post first appeared on the AFP Community Blog.

Raising and lowering barriers to preventive services in the U.S.

The Affordable Care Act's guarantee of no cost-sharing for cancer screenings and other beneficial evidence-based preventive services recommended by the U.S. Preventive Services Task Force (USPSTF) has been put in jeopardy by a district court decision favoring the plaintiffs in a lawsuit claiming that requiring insurance coverage of HIV pre-exposure prophylaxis violated their religious freedom. Judge Reed O'Connor ruled that because USPSTF members are not confirmed by the Senate and their recommendations are not subject to government oversight or approval, health insurers are no longer obligated to cover any preventive services recommended after the ACA was signed into law in March 2010. Mandatory coverage of services endorsed by other governmental bodies, such as the Advisory Committee on Immunization Practices (ACIP) and the Health Resources and Services Administration (HRSA), will remain in effect. In a previous blog post, I called this outcome "an exceedingly dumb and harmful proposition that would result in more preventable illness and poorer quality of life for millions of Americans," but now that it's happened, it is worth exploring why the ACA left the Task Force vulnerable and what can be done to repair the damage.

In 2013, family physicians Steven Woolf and Doug Campos-Outcalt wrote a prescient viewpoint in JAMA noting that the USPSTF's exclusive focus on the scientific evidence of clinical benefits and harms made it ill-equipped to implement insurance policy designs:

Coverage decisions, like other aspects of public policy, should not always be dictated solely by science. ... Just as clinicians must consider individual circumstances that transcend empirical data, the public should be allowed to influence policy choices, like paying for services, when factors other than science pertain. Laws should certainly adhere to the evidence in ensuring public access to a minimum set of services of proven benefit, but the latitude to build on this evidence-based “floor” should also be preserved. ... Placing the USPSTF in this position puts its analytic rigor at risk by preventing members from concentrating on the science. The inescapable reality that their conclusions dictate coverage guidelines may engender a subliminal pressure to reinterpret the evidence, knowing the ramifications, and to lower the threshold for A and B recommendations.

Drs. Woolf and Campos-Outcalt suggested severing the link between USPSTF recommendations and coverage policy "by naming a separate body to advise the secretary of Health and Human Services on appropriate preventive services for first-dollar coverage." This did not happen, of course, even after three former Task Force Chairs published a second commentary a few years later asking "Is It Time for the USPSTF to Inform—But Not Determine—Coverage?" Discussing an attempt by Mylan, the manufacturer of the EpiPen, to pressure the panel to declare its anaphylaxis drug a preventive service so that insurance companies would be forced the bear the full burden of future price increases, the authors noted that "the linkage ... encourages those with a significant financial interest to attempt to influence the direction and decisions of the Task Force."

In a recent Health Affairs Forefront article, Richard Hughes IV and colleagues discussed potential policy solutions that would save the ACA's preventive coverage provision and strengthen the USPSTF's position against inevitable future challenges. (As a physician who has cared for countless patients with this chronic infectious disease, it boggles my mind that 40 years after the discovery of the HIV virus as the cause of AIDS, at-risk and affected patients remain stigmatized for "immoral" behavior.) Although it is unlikely that Congress will act, administrative reforms are possible. For example, "the HHS Secretary could authorize the director of the Agency for Health Care Research and Quality or the CDC director to review and adopt the Task Force's recommendations." Or, echoing Woolf and Campos-Outcalt, "the Administration could establish an additional body within HHS to provide additional review, oversight and approval of recommendations. This group could be a vehicle for badly needed reforms to better align criteria, processes and recommendations across the various recommending bodies."

 

Even if this legal quandary is resolved, either by appeals to higher courts or executive actions such as those proposed above, the fact remains that "free" health care services, preventive or not, are not free if taking time off work to receive them results in lost income. Only 16 states and Washington, DC require employers to provide paid sick leave, and nearly 30% of workers lack it as a result, with higher proportions among people with low incomes, women, and underserved minority groups. An innovative study by Dr. Kevin Callison and colleagues examined the association between paid sick leave mandates and screening for colorectal and breast cancers using administrative claims data. Even though employees presumably use paid sick leave mostly for acute illnesses and non-preventive care, the researchers found that cancer screening rates were significantly higher in metropolitan statistical areas with paid sick leave mandates. Requiring that employers provide paid sick leave throughout the U.S. would not only lower a barrier to receiving beneficial preventive services, but as the COVID-19 pandemic demonstrated, likely drive overall population health improvement as well.

Potential downsides of ADHD overdiagnosis

Over the past few decades, U.S. children have become increasingly likely to receive a diagnosis of attention-deficit/hyperactivity disorder (ADHD), according to multiple national surveys. This unexplained rise in prevalence may be partly due to overdiagnosis, suggested a Lown Right Care article by Dr. Elizabeth Wolf and colleagues in the March issue of American Family Physician. They noted that the characteristic traits of ADHD – hyperactivity, inattentiveness, and impulsiveness – “exist on a continuum with normal behavior,” and that disease cutoffs have been gradually lowered, culminating in the DSM-5 diagnostic criteria which “lowered the percentage of criteria needed for diagnosing ADHD in older adolescents and increased the age by which behaviors must have first appeared (from seven to 12 years).” Evidence of situational ADHD overdiagnosis includes wide variations in stimulant prescriptions across states, higher rates in children who are young for their school grade, and comorbid learning and psychiatric disorders that may be mistaken for ADHD.

Although children diagnosed with ADHD can qualify for individualized education plans, and those with moderate to severe symptoms who take stimulant medications show improvements in math and reading performance, the benefit of diagnosing a child with mild symptoms is less clear. Harms of an ADHD diagnosis include labeling, disempowerment, lowered school expectations, the opportunity costs of medical visits (e.g., missed work for parents), and medication adverse effects, including insomnia. In an accompanying patient perspective, Helen Haskell and John James expressed concern that “medicating children to change their behavior may help them sit quietly at school, but viewing medication as a first-line solution may mask problems with the school or home environment and inhibit the development of important life skills.”

A recent episode of the Pharmanipulation podcast, featuring interviews with a licensed clinical psychologist and an investigative journalist, further explored the subjectivity involved in ADHD diagnoses and educational and societal pressures that may be driving these diagnoses in borderline cases. For example, the Vanderbilt Assessment Scales that are completed by a child’s parents and teachers to assist with diagnosing ADHD “[take] a subjective impression and quantify it so that it makes it seem objective.” If the parent or teacher already thinks that the child has ADHD, they will be more likely to complete the questionnaire in a way that leads to the diagnosis. Having ADHD makes a child likely to receive pharmacologic treatment, even though psychosocial interventions such as parent training in behavioral management and classroom behavior interventions can also be effective, particularly in younger children.

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This post first appeared on the AFP Community Blog.

Carried by deer ticks, babesiosis is spreading in the northeastern U.S.

The Centers for Disease Control and Prevention reported last week that the incidence of babesiosis rose substantially in 10 northeastern states from 2011 to 2019, including Maine, New Hampshire, and Vermont, where it was not previously considered to be endemic. Maps from a previous American Family Physician article on tickborne diseases illustrate the geographic distribution of babesiosis compared to other tickborne diseases such as Lyme disease. Babesiosis is usually transmitted to humans by the bite of an infected deer tick (Ixodes scapularis), though rare cases of transfusion-associated and perinatal transmission have been reported.

The Environmental Protection Agency has concluded that the expanding range of disease-carrying ticks to northern latitudes has been influenced by ongoing climate change:

Deer ticks are mostly active when temperatures are above 45˚F, and they thrive in areas with at least 85-percent humidity. Thus, warming temperatures associated with climate change are projected to increase the range of suitable tick habitat. … Because tick activity depends on temperatures being above a certain minimum, shorter winters could also extend the period when ticks are active each year. … Unlike some other vector-borne diseases, tick-borne disease patterns are generally less influenced by short-term changes in weather (weeks to months) than by longer-term climate change.

After an incubation period of one to nine weeks, patients with babesiosis can experience nonspecific flulike symptoms, including fever, generalized weakness, and myalgias. More severe complications may develop, including acute respiratory distress syndrome, congestive heart failure, and disseminated intravascular coagulation. The diagnosis can be made by polymerase chain reaction (PCR) or microscopic identification of intraerythrocytic organisms on a Giemsa-stained peripheral blood smear.

First-line treatment for mild to moderate babesiosis is oral atovaquone and azithromycin for 7 to 10 days. More severe infections should be treated with intravenous clindamycin and oral quinine. Exchange transfusions are “reserved for patients who are extremely ill – with blood parasitemia of more than 10 percent, massive hemolysis and asplenia.” Since co-infection with Lyme disease and ehrlichiosis can occur, clinicians can consider starting oral doxycycline while awaiting the results of serologic testing. Babesiosis may persist for more than two months after effective treatment and for months to years in patients with unrecognized infections.

A previous AFP editorial provided advice on use of effective insect repellents to prevent diseases carried by ticks and mosquitoes. A patient education handout reviewed strategies for preventing tick bites and safely removing attached ticks. Finally, readers interested in mitigating infectious and other health impacts of warming temperatures in their clinics and communities can consult a curated collection of articles on environmental health and climate change.

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This post first appeared on the AFP Community Blog.