Monday, October 26, 2020

Debating the pros and cons of Medicare for All

Although neither of the major party nominees for U.S. President in November support a "Medicare for All" style single-payer health insurance program, this issue emerged during the Democratic primary debates as one option for extending coverage to the uninsured and reducing health care administrative costs. Our recent Georgetown Health Policy Journal Club discussed two editorials in the October 1 issue of American Family Physician that offered contrasting answers to the question: "Would Medicare for All Be the Most Beneficial Health Care System for Family Physicians and Patients?"

In "Yes: Improved Medicare for All Would Rescue an American Health Care System in Crisis," Dr. Ed Weisbart argued that the COVID-19 pandemic exposed the shortcomings in an employer-based health insurance system with an patchwork public insurance safety net. He pointed out that 93% of U.S. primary care physicians accept Medicare, and Medicare enrollment has been associated with improvements in age-specific mortality relative to peer nations. In addition, Dr. Weisbart suggested that implementing an expanded version of Medicare with more comprehensive coverage for the entire population would lead to large administrative cost savings, reduce documentation burden, and potentially increase primary care physician satisfaction by eliminating the moral injury associated with being unable to help patients who cannot afford care.

In "No: Medicare for All Would Cause Chaos and Fail to Control Health Care Costs," Dr. Richard Young countered that "expansion of Medicare ... would not address the deeper problems in our health care system." At current payment rates, implementation of Medicare for All could cause substantial financial difficulties for hospitals. Absent new legislation to allow the Centers for Medicare and Medicaid Services (CMS) to negotiate drug prices and consider costs in coverage determinations, he pointed out, expanding Medicare would further inflate the already staggering U.S. health care bill. Dr. Young argued that regardless of their financing mechanisms, other countries with universal coverage have lower costs primarily because their citizens are willing to sacrifice - whether that means practicing within strict budget limits (e.g., fewer cancer screenings, more conservative prescribing of statins) or declining to cover some beneficial but very expensive therapies. Finally, he observed that

many of the things that frustrate family physicians about the current [U.S. health care] system originated with Medicare: the devaluation of primary care services; the relative overpayment for specialist care; the inability to bill for helping patients with more than two or three concerns in one visit; the requirement for face-to-face services (before the coronavirus disease 2019 exceptions took effect); the refusal to pay family physicians for clinic and hospital work on the same day; and the lack of incentives for full-scope family medicine.

A 2019 RAND study estimated that total national health expenditures under a Medicare for All plan would increase by only 1.8%, from $3.82 to $3.89 trillion annually. However, the federal government's direct share of health care spending would rise by 220%, from $1.1 to $3.5 trillion, an increase that would have represented more than half of 2019 federal expenditures and exceeded the $2 trillion plus CARES Act economic relief package passed earlier this year.

We also discussed less ambitious (and, possibly, more politically palatable) proposals for extending coverage that build on the framework of the Affordable Care Act, such as adding a publicly administered insurance option to increase competition (and lower premium costs) in the state health marketplaces. Former Vice President Biden has expressed support for "Medicare for More," extending Medicare eligibility to persons age 60 to 64 and possibly allowing younger adults without affordable insurance options to "buy in" to the program. The upcoming Presidential and Congressional elections will clearly play a critical role in determining if our country moves in that direction.

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This post first appeared on The Health Policy Exchange.

Friday, October 23, 2020

Cancer survivorship: what is the family physician's role?

Family physicians' expertise in cancer mostly involves screening and diagnosis, while treatment is managed by medical and/or surgical oncologists. However, as the long-term survival of patients with cancer improves, the important care role of primary care clinicians in survivors of childhood and adult cancers has been increasingly recognized. The National Cancer Institute estimated that in 2019, cancer survivors numbered 16.9 million, or about 5 percent of the U.S. population. During the past few years, American Family Physician has published clinical reviews of the American Cancer Society's guidelines on primary care for survivors of prostate cancer, colorectal cancer, and breast cancer. The American Academy of Family Physicians' policy on Cancer Care recommends that "the physician workforce, including family physicians, should be educated about the protocols for survivorship management."

A recent qualitative study published in the Annals of Family Medicine found that the reality on the ground is more complex than current guidelines and policy suggest. Dr. Benjamin Crabtree and colleagues recorded lengthy interviews with 38 clinicians in 14 U.S. primary care practices that had been previously recognized for workforce innovation by the Robert Wood Johnson Foundation. In these interviews, clinicians were "asked to describe how they viewed their role in cancer survivorship, decisions of when and where to refer patients, and knowledge about new primary care–friendly survivorship care guidelines."

Analysis of the interviews revealed a lack of consensus about the role of primary care in cancer survivorship. For example, several clinicians felt that follow-up cancer care was exclusively the responsibility of oncologists, but the majority expressed that providing this care fell within their purview. However, they reported obstacles ranging from inadequate knowledge / education to "an uneasy relationship with oncology" and a lack of clarity about when care could be transitioned from the oncologist to primary care.

Clinicians also disagreed about whether cancer survivors should be treated as a "distinct patient population" (requiring a systematic health system approach) or like any other patient with a chronic disease. The researchers theorized that these divergent views reflected an "identity crisis" about their care roles for these patients:

Several clinicians expressed mixed opinions, contradicted themselves, vacillated on their stance, or paused when asked about their/primary care’s role in cancer survivorship care. In fact, some clinicians struggled to talk about cancer survivorship at all in their interviews. ... These clinicians, with an identity based on delivering whole-person, comprehensive, coordinated care, appeared to hit a wall of identity confusion when confronted with a swiftly changing highly specialized knowledge base and a highly variable group of patients referred to as “cancer survivors.”

Options for resolving this identity crisis, according to the researchers, could involve developing new cancer-focused curricula for primary care residency programs and continuing medical education; constructing more well-defined management boundaries between primary care and oncology; and/or having their professional organizations "consider coproducing and translating new knowledge about care for cancer survivors that primary care clinicians can prioritize, personalize, and integrate to address patients’ needs and values within a shared decision-making framework." With the population of cancer survivors expected to increase by 30 percent over the next decade, clarifying the appropriate role of family physicians remains an urgent national need.

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This post first appeared on the AFP Community Blog.

Thursday, October 15, 2020

Should scientific publications endorse political candidates?

The New England Journal of Medicine and Scientific American are widely considered to be the preeminent medical research and popular science journals in the world. Since their respective foundings in 1812 and 1845, their editorial staffs have had the opportunity to weigh in on at least 43 American Presidential elections. That they both refrained from doing so until this year is testimony to the traditional separation between science and politics, and the recognition that their subscriber bases are ideologically diverse enough that publicly supporting a major party candidate could lead to many cancelled subscriptions. Nonetheless, both journals recently decided that if there was ever a year to endorse a Presidential candidate, it was 2020.

Here's an excerpt from Scientific American's full-throated endorsement of former Vice President Joe Biden:

The evidence and the science show that Donald Trump has badly damaged the U.S. and its people—because he rejects evidence and science. The most devastating example is his dishonest and inept response to the COVID-19 pandemic, which cost more than 190,000 Americans their lives by the middle of September. He has also attacked environmental protections, medical care, and the researchers and public science agencies that help this country prepare for its greatest challenges. That is why we urge you to vote for Joe Biden, who is offering fact-based plans to protect our health, our economy and the environment. These and other proposals he has put forth can set the country back on course for a safer, more prosperous and more equitable future.

In contrast, the New England Journal of Medicine editors mentioned neither President Trump nor his Democratic challenger by name in "Dying In A Leadership Vacuum," but it's clear that they blame the federal government, and by extension its elected leader, for the United States' failure to control the pandemic:

Our current leaders have undercut trust in science and in government, causing damage that will certainly outlast them. Instead of relying on expertise, the administration has turned to uninformed “opinion leaders” and charlatans who obscure the truth and facilitate the promulgation of outright lies. ... Some deaths from Covid-19 were unavoidable. But, although it is impossible to project the precise number of additional American lives lost because of weak and inappropriate government policies, it is at least in the tens of thousands in a pandemic that has already killed more Americans than any conflict since World War II. Anyone else who recklessly squandered lives and money in this way would be suffering legal consequences. Our leaders have largely claimed immunity for their actions. But this election gives us the power to render judgment.

Setting aside financial consequences, the danger of a scientific journal, or a medical blog for that matter, taking a partisan stand is that at least some of its readers will perceive it as politically biased and either view all subsequent content through a lens of suspicion or abandon it completely. The handful of times I have endorsed or criticized a prominent politician on Common Sense Family Doctor, there has been a backlash in the form of angry comments and lost subscribers. Because my goal is to reach and influence as many people as possible, I carefully cultivate my reputation as a "straight shooter" on health care and other factors that affect personal and community health.

On the other hand, election results have huge heath consequences, especially in the midst of a pandemic that has already killed more than 216,000 Americans and hospitalized hundreds of thousands more. It's indisputable that the outcomes of our national response have been abysmal compared to that of high-income countries. A study in JAMA this week reported that since May 10, the United States has had more COVID-19 deaths per 100,000 persons than 18 comparable nations; since June 7, we've had nearly 8 times as many deaths per capita than Canada, 23 times as many as Switzerland, and 90 times as many as Finland.

I've written before about how the different ways in which the two major political parties view liberty - as "freedom to" versus "freedom from" - have shaped their perspectives on civil rights and health care legislation. Some people (mostly Democrats) who support more stringent federal and state public health measures to suppress the virus argue that these are necessary to protect the freedom of individuals (and particularly, vulnerable persons) to live their lives without contracting a crippling or potentially fatal disease for which effective therapies and vaccines aren't yet available. Others (mostly Republicans) who oppose these measures or feel that they've gone too far do so from a desire to be free from onerous (and often arbitrary) restrictions on private and public gatherings, schools, businesses, and mask mandates. The scope of this partisan divide is exaggerated by the media's obsessive coverage of behavioral outliers (e.g., mask-less partying college students) and polls that supposedly show mounting distrust in a COVID-19 vaccine that doesn't yet exist. The truth is, the vast majority of Americans want to mitigate the spread of the disease, and nonpartisan behavior change strategies can improve our adherence to protective behaviors regardless of our Presidential preferences.

Returning to the question that is the title of this post, my feeling is that a Presidential endorsement in a scientific journal isn't going to change anyone's mind, but could damage the publication's credibility with some portion of its readers. So you won't see American Family Physician endorsing a candidate in this or any future election as long as I'm a deputy editor, and Common Sense Family Doctor won't be jumping on a Presidential bandwagon, either. What you will get from me is the evidence above that America has thus far done a very poor job fighting the virus. How much of that failure is the fault of President Trump and his administration, and whether a Biden administration could do better, should play a role in who earns your vote, as it did mine.

Friday, October 9, 2020

Is physical therapy helpful for acute back pain with sciatica?

Although a referral to physical therapy is a standard part of my treatment plan for patients with subacute or chronic low back pain, there is little data on the effectiveness of physical therapy for acute back pain. A 2018 Family Physicians Inquiries Network (FPIN) Clinical Inquiry published in American Family Physician found that physical therapy begun within 24 hours of clinical presentation provides minimal improvements in pain, satisfaction, and mental health at one week that disappear by one month. Physical therapy started within 48 to 72 hours of presentation had no significant effects on pain or disability. A 2002 randomized trial found no differences in pain or activities of daily living in patients with acute low back pain with sciatica who were assigned to bed rest, physical therapy, or a control group. A 2008 study reported that physical therapy added to usual care from a general practitioner improved patients' global perceived effect but had no effects on pain or disability. Another FPIN Clinical Inquiry on treatments for sciatica concluded that nonsteroidal anti-inflammatory drugs, systemic steroids, topiramate, pregabalin, traction, and best rest were all ineffective and had potential adverse effects. The authors did not review physical therapy.

A single-blind randomized controlled trial published this week in the Annals of Internal Medicine compared early referral to physical therapy to usual care in 220 adults aged 18 to 60 years with acute back pain with sciatica for less than 90 days. Participants were recruited from primary care practices in two health care systems (Intermountain Healthcare and University of Utah). All participants received an evidence-based patient education booklet about low back pain; patients assigned to the intervention group were scheduled for 6 to 8 exercise and manual therapy sessions over 4 weeks with one of the study physical therapists. The primary outcome was change in the Oswestry Disability Index (OSW) score from baseline after 6 months.

Compared to the usual care group, intervention group participants reported greater improvements in OSW scores at 6 months (5.4 points) and 1 year (4.8 points). They also had lower back pain intensity and were more likely to report treatment success after 1 year (45% vs. 28% for usual care). However, health care use and missed workdays were not significantly different between groups.

Although this study's results appear to support early referral to physical therapy for patients with acute back pain with sciatica, they come with some caveats. The minimal clinically important difference on the OSW for this condition is 6 to 8 points, greater than the mean point estimates of between-group differences seen in this study. Also, since participants were not blinded to their group assignment and the usual care group did not receive sessions with a comparable contact time as the physical therapy sessions, it's possible that the modest improvement had less to do with the therapy than the caring attention that patients received from the therapists. The cost-effectiveness of referring every patient with this condition to a physical therapist is also uncertain.

Nonetheless, given the limited options currently available for patients with acute back pain with sciatica, it seems reasonable to refer to a physical therapist rather than prescribe ineffective drug therapy or order unnecessary and potentially harmful imaging studies.

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This post first appeared on the AFP Community Blog.

Friday, October 2, 2020

The President of the United States has COVID-19

Two years ago, I collaborated with colleagues from Georgetown's School of Nursing & Health Studies on a peer-reviewed article explaining the complex interpretation and management of Zika virus test results in the Journal of the American Board of Family Medicine. After COVID-19 began spreading in the United States this spring, our team reunited virtually and added a fifth collaborator (a 4th year medical student in Georgetown's Population Health Scholar Track) to outline a practical approach to the interpretation of COVID-19 test results in clinical settings. This week, JABFM published our new paper online ahead of print in its COVID-19 subject collection.

The paper includes three clinical scenarios that illustrate the application of testing principles to hypothetical persons with a low, moderate, and high pretest probability of having COVID-19, respectively. The manuscript we initially submitted to the journal included the following scenario:

Scenario 3 – High pretest probability (RT-PCR)

A 28-year-old female White House staffer with unremarkable past medical history spent two hours meeting in person with another staffer who was diagnosed the next day with COVID-19. Five days later, she developed a temperature of 101.5 degrees Fahrenheit, a nonproductive cough, and loss of taste and smell. A rapid molecular SARS-CoV-2 test is negative. She is relieved at the test result because she will be meeting with the President tomorrow.

Let’s say that her pretest probability was 80%, given her direct contact with an individual who tested positive and development of classic COVID-19 symptoms. As she is symptomatic, the timing of testing with RT-PCR is appropriate. Suppose her test has a sensitivity of 90% and specificity of 95%. The predictive value for a positive test result is 98.6% and a negative test result is 70.4%. There is a 70% chance the staffer with a negative result actually does have SARS-CoV2 infection. Suppose that she was given a test with lower sensitivity of 80%. While the positive predictive value would still be high at 98.5%, the negative predictive value would drop significantly to 54.3%. In either case, a negative test result does not rule out COVID-19. In other words, a negative molecular test result in an individual with high clinical suspicion or high pretest probability for COVID-19 should be interpreted with caution, especially when tests have low sensitivity. Despite testing negative, this individual should self-isolate for 10 days.


One of the peer reviewers asked us to rewrite this scenario in our revision because he or she felt that using a White House staffer as an example was "gratuitous," "unnecessarily provocative," and "introduces politics into discussion that we need to strive to remain apolitical." We decided to change the patient in the scenario to a college student with a fever who had recently been in close contact with a resident in her dormitory who had tested positive for COVID-19. We in no way intended for it to be prophetic, even though White House senior counselor Hope Hicks, the presumed source for the President's and First Lady Melania Trump's recently diagnosed infections, is 31 years old and tested positive after experiencing mild flulike symptoms on a return flight from a campaign rally on Wednesday evening.

News accounts thus far indicate that White House medical staff have followed CDC guidance since Ms. Hicks's diagnosis, immediately placing the President and First Lady in quarantine since they had been exposed and in isolation now that they have tested positive. They will need to self-isolate for at least 10 days or, should either develop symptoms, 24 hours after fever resolves, whatever is later. Setting aside my personal politics and the upcoming Presidential election, I wish them both a speedy and uneventful recovery. As for the rest of us: if the most powerful man in the world, who has hundreds of highly skilled protective and medical personnel working around the clock to keep him physically safe and in good health, can contract COVID-19, so can you. Wash your hands. Keep your distance. And most importantly, wear a mask.

Friday, September 25, 2020

Coronavirus vaccine is unlikely to be a "magic bullet" that ends the pandemic

Last week, federal health officials announced an ambitious plan to begin free distribution of a vaccine against SARS-CoV-2 within 24 hours of its approval or emergency authorization from the U.S. Food and Drug Administration (FDA). That an efficacious vaccine could, remarkably, become available less than one year after the isolation of the virus that causes COVID-19 is due in part to a public-private program to accelerate vaccine, diagnostic test, and therapy development led by the U.S. Departments of Defense and Health and Human Services known as "Operation Warp Speed." In a New England Journal of Medicine commentary, Drs. Moncef Slaui, Shannon Greene, and Janet Woodcock reviewed the progress of Operation Warp Speed on multiple fronts, including the most promising candidate vaccines in phase 2 and 3 clinical trials. Ultimately, though, the impact of any vaccine on the course of the pandemic in the U.S. and abroad will depend not only on how protective it is against infection and disease transmission, but how the allocation of initially limited supplies is prioritized (e.g., health care and essential workers, vulnerable groups) and what proportion of the population agrees to receive it in the absence of a requirement to do so.

A simulation study in the American Journal of Preventive Medicine estimated the efficacy and percent population coverage that a coronavirus vaccine would need to extinguish the epidemic in the absence of other public health measures such as social distancing and wearing face coverings - in other words, what it would take for a vaccine to allow life to "go back to normal." The effects of a vaccine on productivity losses, hospitalizations, medical costs, and deaths vary depending on what percentage of the population has already been exposed to SARS-CoV-2; one seroprevalence survey from late March to mid-May found a range from 1% to 7% at 10 sites in the U.S., but these figures are likely to be higher four or more months later. To extinguish the epidemic after 5% of the population has been exposed, for example, the AJPM researchers calculated that a vaccine would need to have at least 80% efficacy if administered to 75% of the population.

Unfortunately, expecting any of the coronavirus vaccines in development to have 80% efficacy is unrealistic.  By comparison, the Centers for Disease Control and Prevention (CDC) estimated that the 2019-20 influenza vaccine was only 45% effective, consistent with the 40-60% range in previous years when the available vaccines were antigenically matched to circulating influenza viruses. The highest influenza vaccine coverage was during the 2018-19 season, when 63% of children (state range, 46%-81%) and 45% of adults (state range, 34%-56%) received the vaccine. Although some may be more willing to be vaccinated against SARS-CoV-2 than influenza due to the former's greater morbidity and mortality, influenza vaccine also has a long safety track record that a coronavirus vaccine would not.

It is possible that public health measures in place to slow the spread of COVID-19 will substantially reduce the impact of influenza during the 2020-21 season. A CDC surveillance report showed that U.S. cases of laboratory-confirmed influenza fell sharply after the national COVID-19 emergency declaration on March 1, reflecting not only the natural waning of the flu season but also mitigation interventions implemented by states around this time. In the Southern Hemisphere nations of Australia, Chile, and South Africa, where influenza activity normally peaks in June or July, COVID-19 mitigation was associated with a near-complete suppression of influenza circulation.

For family physicians, preparing for flu season during the COVID-19 pandemic, with a coronavirus vaccine potentially around the corner, means adapting to many uncertainties. What hasn't changed from previous years is that the CDC's Advisory Committee on Immunization Practices continues to recommend influenza vaccination for all people six months and older who do not have contraindications, ideally by the end of October. Whenever it arrives, the coronavirus vaccine is unlikely to be a "magic bullet" that ends the pandemic on its own. So it's critical that clinicians all continue to echo the message about cloth face coverings that CDC Director Robert Redfield, MD delivered at a recent Senate hearing: "These face masks are the most important, powerful public health tool we have" for controlling the pandemic.

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The post first appeared on the AFP Community Blog.