Friday, December 27, 2024

Primary care for all Americans

"The Gilded Age of Medicine is Here," announced the title of a recent New Yorker article about the tactics of private equity firms that provide infusions of cash to struggling hospitals in order to extract hundreds of millions of dollars in profits by slashing costs to the bone and endangering the health of patients. As Dr. Dhruv Khullar writes, "They [private equity] are hardly the only corporations to learn this lesson. Increasingly, health insurers, private hospitals, and even nonprofits are behaving as though they aim first to extract revenue, and only second to care for people. People often are viewed less as humans in need of care than consumers who generate profit." Dr. Don Berwick's dire warning about the existential threat of greed on the failing American health care system seems to be coming true, to the extent that the brazen assassination of an insurance company executive in midtown Manhattan elicited far more outrage about delayed or denied care than sympathy for his family's loss.

Nevertheless, the U.S. is at the threshold of a once-in-a-lifetime opportunity. In 2023, a decade after the Affordable Care Act expanded Medicaid and began offering subsidized private insurance options in national and state-run marketplaces, the share of the population with health insurance reached 92.5% - the highest ever. Contrary to many predictions, the ACA coverage expansions did not increase health care spending growth. For the first time in history, then, America is on the brink of near-universal insurance coverage, despite the incoming administration's determination to roll back many of the policies that got us to this point.

We should no longer be debating whether or not having health care insurance is better than not having it. What we should be discussing is why health care costs keep climbing so rapidly, which leads directly to higher premiums and the proliferation of high-deductible policies that make accessing care unaffordable even for the insured. In some cases, more regulations are the answer. Both political parties have belatedly recognized, for example, that the inflated costs of prescription drugs are due not only to pharmaceutical company avarice but also pharmacy benefit managers (PBMs) that "steer patients toward pricier drugs, charge steep markups on what would otherwise be inexpensive medicines and extract billions of dollars in hidden fees," not only hurting patients and employers but driving independent local drugstores out of business.

Even if drugmakers and PBMs could be brought to heel, though, America is still lacking a major ingredient of a truly patient-centered health system: well-resourced, adequately supported primary care. These days, most adults need to wait several months for a new patient appointment with a family doctor, if they can get one at all. This isn't only because too few medical students are choosing primary care residency programs; it also reflects generalist physicians leaving practice prematurely due to burnout.

There are hopeful signs that policymakers are finally waking up to the need to provide more support to primary care. The 2021 National Academy of Medicine report "Implementing High-Quality Primary Care: Rebuilding the Foundation of Health Care" advanced the concept of primary care as a common good rather than a commodity. The Primary Care Collaborative's 2024 Evidence Report found that primary care centric Accountable Care Organizations produce more than twice as much net savings as ACOs with smaller proportions of primary care clinicians. The state of Massachusetts is now proposing a prospective payment model to double primary care investment, while the Centers for Medicare and Medicare Services is adding payments for "advanced primary care management" to compensate practices for core tasks that they are already doing or should be doing anyway.

But it's not enough to wait and hope that policymakers will figure this out on their own. A grassroots movement is underway. A few months ago, I found myself in a conference room in Philadelphia listening to speakers introduce Primary Care for All Americans, a volunteer organization whose mission is to bring people from all walks of life together "to create a health care system that is for people, not for profit, that serves all Americans, in every neighborhood and community." PCAA hosts weekly online conversations about making primary care accessible for all and provides resource-packed state and local playbooks for individuals who are looking to support primary care in their states and communities. Join the movement and seize this opportunity to bring an end to the Gilded Age of American medicine.

Saturday, December 14, 2024

Overtreatment of prostate cancer in the active surveillance era

Concerns about overdiagnosis of clinically insignificant prostate cancer through prostate specific antigen (PSA) screening motivated the 2018 American Academy of Family Physicians’ (AAFP) recommendation against routine screening for prostate cancer. Explaining the AAFP’s position, Drs. James Stevermer and Kenneth Fink wrote in an AFP editorial:

Few men diagnosed with and treated for prostate cancer will experience a mortality benefit, and an estimated 20% to 50% of those treated will never become symptomatic, even without treatment. This high rate of overdiagnosis from prostate cancer screening exposes many men to harms without any potential benefit.

Active surveillance is a management strategy that is intended to limit overtreatment of localized prostate cancer by monitoring patients with periodic PSA measurements and prostate biopsies to delay or avoid curative therapy (radical prostatectomy or radiation therapy) and its adverse effects. Watchful waiting refers to clinical observation only. A recent analysis of the U.S. Surveillance, Epidemiology, and End-Results (SEER) prostate cancer database found that among men with intermediate-risk prostate cancer (based on pathology and a PSA level lower than 20 ng/mL), active surveillance or watchful waiting increased overall from 5% in 2010 to 12.3% in 2020, with higher percentages of patients with more favorable pathology or lower PSA levels choosing one of these strategies. Of note, men older than 80 years were more than four times as likely to choose observation than men in their 50s (24.9% and 6.1%, respectively).

Another study of patients in the Veterans Affairs health system examined changes in the likelihood of curative therapy in men with prostate cancer and limited longevity. Guidelines recommend against PSA screening or curative treatment for prostate cancer in men with life expectancies of less than 10 years because the benefits take more than a decade to appear, whereas the harms manifest in the short term. Nonetheless, among men with intermediate-risk prostate cancer and life expectancies of less than 10 years, overtreatment rose from 37.6% in 2000 to 59.8% in 2019, with 78% receiving radiation therapy and 22% undergoing surgery.

Radiation therapy may be viewed by patients and physicians as having fewer adverse effects than surgery, but it is hardly benign. A prospective cohort study of nearly 30,000 men who participated in two prostate cancer prevention trials found that compared with untreated participants, men who had radiation therapy were 2.76 times more likely to develop urinary or sexual complications, 2.78 times as likely to develop bladder cancer, and 100 times as likely to develop radiation cystitis and proctitis. It makes no sense to expose patients to these risks who have little opportunity to benefit, two geriatricians wrote in a JAMA Internal Medicine commentary titled “Do Not Wait to Consider Life Expectancy Until After a Prostate Cancer Diagnosis”:

Limited life expectancy increases the likelihood of experiencing harms all along the diagnostic and treatment cascade following screening. Time spent diagnosing, monitoring, and treating asymptomatic prostate cancer in men with limited life expectancy distracts from monitoring and treating their symptomatic life-limiting illnesses. Also, limited life expectancy increases the likelihood of complications from most procedures, including radiation therapy.

A previous AFP article that reviewed treatment options for localized prostate cancer, including active surveillance, included the patient-administered Charlson Comorbidity Index and a life expectancy table for U.S. men. A 2019 AFP editorial provided more guidance for estimating and having conversations about life expectancy with older patients.

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This post first appeared on the AFP Community Blog.

Wednesday, December 4, 2024

In asymptomatic severe aortic stenosis, is earlier intervention better?

Affecting three in 100 adults older than 65 years, aortic stenosis is classified as mild, moderate, and severe based on echocardiographic measurements. The onset of symptoms—dyspnea, volume overload, angina, syncope—is associated with a poor prognosis and is the usual indication for aortic valve replacement. Although valve replacement traditionally required open surgery, transcatheter aortic valve implantation (TAVI) has become increasingly common. A JAMA review article quotes a 2020 American College of Cardiology/American Heart Association guideline as recommending surgical aortic valve replacement (SAVR) for patients younger than 65 years, TAVI for patients 80 years or older, and either procedure in patients 65 to 79 years, depending on operative risk and comorbidities.

A recent editorial in the Journal of the American Heart Association discussed a “paradigm shift” in management of severe aortic stenosis: 69% of Medicare fee-for-service beneficiaries who underwent aortic valve replacement from 2012-2019 had TAVI, with the percentage undergoing SAVR falling from 75% in 2012 to just 10% in 2019. In addition, the overall volume of procedures tripled during this period, suggesting either a dramatic increase in disease severity or more likely, a lower threshold for intervention.

Whether aortic valve replacement in older adults without symptoms of severe aortic stenosis is more beneficial than waiting for symptoms of left ventricular dysfunction to develop is a topic of ongoing research. Two randomized trials published last month shed some light on this question. In a multicenter trial in the United States and Canada, 901 patients older than 65 years (mean age 75.8 years) with asymptomatic severe aortic stenosis were randomized to early TAVI or guideline-recommended clinical surveillance. The primary endpoint was a composite of death, stroke, or unplanned cardiovascular hospitalization. After a median follow-up of 3.8 years, patients assigned to early TAVI had lower mortality (8.4% vs 9.2%), fewer strokes (4.2% vs 6.7%), and fewer unplanned hospitalizations (20.9% vs 41.7%). Of the clinical surveillance group, 87% eventually underwent aortic valve replacement.

A second trial in the United Kingdom and Australia studied 224 patients (mean age 73 years) with asymptomatic severe aortic stenosis and a cardiac MRI showing myocardial fibrosis, which predicts left ventricular decompensation and a poor long-term outcome. Participants were randomized to early aortic valve replacement or conservative management. Although the primary outcome, a composite of all-cause death and unplanned hospitalization related to aortic stenosis, occurred less frequently in the intervention group (18%) than in the control group (23%), this difference was not statistically significant (hazard ratio = 0.79; 95% CI, 0.44-1.43). An accompanying editorial observed that this trial, which fell short of its target enrollment of 356 patients, was underpowered to detect a difference in the outcome. Further, because of scheduling difficulties, 14% of participants in the intervention group had not received valve replacement at 12 months after enrollment. Finally, based on older guidelines that limited TAVI to patients at high operative risk, 75% of the intervention group had SAVR rather than TAVI.

Although the results of these trials can be interpreted as favoring early TAVI in patients with asymptomatic severe aortic stenosis, more studies are needed to ensure that the “paradigm shift” toward early intervention is based on good evidence rather than surgical preference.

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This post first appeared on the AFP Community Blog.