Letter to CMS: Medicaid Recovery Audit Contractors (RAC) Program

Comment on the Centers for Medicare and Medicaid Services (CMS) proposed rule Medicare Program; Revisions to Payment Policies Under the Comments to CMS on Physician Fee Schedule for Calendar Year 2007

Comment Letter to CMS on the Benefit and Payment Parameters for 2019 Proposed Rule

ACP Comment Letter on CEHRT Flexibility and MU Stage 2 Delay NPRM-2014-06-20

ACP Written Comments to House Select Committee on Coronavirus Crisis Hearing The Need to Overcome Vaccine Hesitancy

ACP Response to the Senate HELP Committee on Lowering Health Care Costs

ACP Response to CDC RFI on a National Testing Collaborative

ACP Comments to HHS on Title X Proposed Rule

ACP Letter to Congressional Leadership On Impact of Proposed ACA Changes

ACP Comment Letter to CMS on the Patient Protection and Affordable Care Act Notice of Benefit and Payment Parameters for PY 2027

Wake-up Call

College Campuses and COVID-19 Mitigation: Clinical and Economic Value

Background: Colleges in the United States are determining how to operate safely amid the coronavirus disease 2019 (COVID-19) pandemic. Objective: To examine the clinical outcomes, cost, and cost-effectiveness of COVID-19 mitigation strategies on college campuses. Design: The Clinical and Economic Analysis of COVID-19 interventions (CEACOV) model, a dynamic microsimulation model, was used to examine alternative mitigation strategies. The CEACOV model tracks infections accrued by students and faculty, accounting for community transmissions. Data Sources: Data from published literature were used to obtain parameters related to COVID-19 and contact-hours. Target Population: Undergraduate students and faculty at U.S. colleges. Time Horizon: One semester (105 days). Perspective: Modified societal. Intervention: COVID-19 mitigation strategies, including social distancing, masks, and routine laboratory screening. Outcome Measures: Infections among students and faculty per 5000 students and per 1000 faculty, isolation days, tests, costs, cost per infection prevented, and cost per quality-adjusted life-year (QALY). Results of Base-Case Analysis: Among students, mitigation strategies reduced COVID-19 cases from 3746 with no mitigation to 493 with extensive social distancing and masks, and further to 151 when laboratory testing was added among asymptomatic persons every 3 days. Among faculty, these values were 164, 28, and 25 cases, respectively. Costs ranged from about $0.4 million for minimal social distancing to about $0.9 million to $2.1 million for strategies involving laboratory testing ($10 per test), depending on testing frequency. Extensive social distancing with masks cost $170 per infection prevented ($49 200 per QALY) compared with masks alone. Adding routine laboratory testing increased cost per infection prevented to between $2010 and $17 210 (cost per QALY gained, $811 400 to $2 804 600). Results of Sensitivity Analysis: Results were most sensitive to test costs. Limitation: Data are from multiple sources. Conclusion: Extensive social distancing with a mandatory mask-wearing policy can prevent most COVID-19 cases on college campuses and is very cost-effective. Routine laboratory testing would prevent 96% of infections and require low-cost tests to be economically attractive. Primary Funding Source: National Institutes of Health.

The Effect of Flat Flexible Versus Stable Supportive Shoes on Knee Osteoarthritis Symptoms: A Randomized Trial: Annals of Internal Medicine: Vol 174, No 4

Background: Experts recommend that persons with knee osteoarthritis wear stable supportive shoes; however, evidence suggests that flat flexible shoes may be more beneficial. Objective: To compare flat flexible with stable supportive shoes for knee osteoarthritis symptoms. Design: Participant- and assessor-blinded randomized trial. (Prospectively registered with the Australian New Zealand Clinical Trials Registry [ACTRN12617001098325]) Setting: Community. Participants: 164 patients with moderate to severe symptomatic radiographic medial knee osteoarthritis. Intervention: Flat flexible (n = 82) or stable supportive shoes (n = 82), worn for at least 6 hours a day for 6 months. Measurements: Primary outcomes were changes in walking pain (measured by an 11-point numerical rating scale) and physical function (as assessed by the Western Ontario and McMaster Universities Osteoarthritis Index subscale of 0 to 68 points) at 6 months. Secondary outcomes included additional pain and function measures, physical activity, and quality of life. Other measures included adverse events. Results: Of 164 participants recruited, 161 (98%) completed 6-month primary outcomes. No evidence was found that flat flexible shoes were superior to stable supportive shoes in primary outcomes. Evidence did show a between-group difference in change in pain favoring stable supportive shoes (mean difference, 1.1 units [95% CI, 0.5 to 1.8 units]; P = 0.001) but not function (mean difference, 2.3 units [CI, −0.9 to 5.5 units]; P = 0.167). Improvements in knee-related quality of life and ipsilateral hip pain favored stable supportive shoes (mean difference, −5.3 units [CI, −10.0 to −0.5 units] and 0.7 units [CI, 0.0 to 1.4 units], respectively). Flat flexible shoes were not superior to stable supportive shoes for any secondary outcome. Fewer participants reported adverse events with stable supportive shoes (n = 12 [15%]) compared with flat flexible shoes (n = 26 [32%]) (risk difference, −0.17 [CI, −0.30 to −0.05]). Limitation: No “usual shoes” control group and a select patient subgroup, which may limit generalizability. Conclusion: Flat flexible shoes were not superior to stable supportive shoes. Contrary to our hypothesis, stable supportive shoes improved knee pain on walking more than flat flexible shoes. Primary Funding Source: National Health and Medical Research Council.

Comparative Effectiveness and Harms of Antibiotics for Outpatient Diverticulitis: Two Nationwide Cohort Studies: Annals of Internal Medicine: Vol 174, No 6

Background: Outpatient diverticulitis is commonly treated with either a combination of metronidazole and a fluoroquinolone (metronidazole-with-fluoroquinolone) or amoxicillin–clavulanate alone. The U.S. Food and Drug Administration advised that fluoroquinolones be reserved for conditions with no alternative treatment options. The comparative effectiveness of metronidazole-with-fluoroquinolone versus amoxicillin–clavulanate for diverticulitis is uncertain. Objective: To determine the effectiveness and harms of metronidazole-with-fluoroquinolone versus amoxicillin–clavulanate for outpatient diverticulitis. Design: Active-comparator, new-user, retrospective cohort studies. Setting: Nationwide population-based claims data on U.S. residents aged 18 to 64 years with private employer-sponsored insurance (2000 to 2018) or those aged 65 years or older with Medicare (2006 to 2015). Participants: Immunocompetent adults with diverticulitis in the outpatient setting. Intervention: Metronidazole-with-fluoroquinolone or amoxicillin–clavulanate. Measurements: 1-year risks for inpatient admission, urgent surgery, and Clostridioides difficile infection (CDI) and 3-year risk for elective surgery. Results: In MarketScan (IBM Watson Health), new users of metronidazole-with-fluoroquinolone (n = 106 361) and amoxicillin–clavulanate (n = 13 160) were identified. There were no differences in 1-year admission risk (risk difference, 0.1 percentage points [95% CI, −0.3 to 0.6]), 1-year urgent surgery risk (risk difference, 0.0 percentage points [CI, −0.1 to 0.1]), 3-year elective surgery risk (risk difference, 0.2 percentage points [CI, −0.3 to 0.7]), or 1-year CDI risk (risk difference, 0.0 percentage points [CI, −0.1 to 0.1]) between groups. In Medicare, new users of metronidazole-with-fluoroquinolone (n = 17 639) and amoxicillin–clavulanate (n = 2709) were identified. There were no differences in 1-year admission risk (risk difference, 0.1 percentage points [CI, −0.7 to 0.9]), 1-year urgent surgery risk (risk difference, −0.2 percentage points [CI, −0.6 to 0.1]), or 3-year elective surgery risk (risk difference, −0.3 percentage points [CI, −1.1 to 0.4]) between groups. The 1-year CDI risk was higher for metronidazole-with-fluoroquinolone than for amoxicillin–clavulanate (risk difference, 0.6 percentage points [CI, 0.2 to 1.0]). Limitation: Residual confounding is possible, and not all harms associated with these antibiotics, most notably drug-induced liver injury, could be assessed. Conclusion: Treating diverticulitis in the outpatient setting with amoxicillin–clavulanate may reduce the risk for fluoroquinolone-related harms without adversely affecting diverticulitis-specific outcomes. Primary Funding Source: National Institutes of Health.

Public Health Interventions, Epidemic Growth, and Regional Variation of the 1918 Influenza Pandemic Outbreak in a Swiss Canton and Its Greater Regions

Public health interventions implemented during the coronavirus disease 2019 (COVID-19) pandemic are based on experience gained from past pandemics. The 1918 influenza pandemic is the most extensively researched historical influenza outbreak. All 9335 reports available in the State Archives on 121 152 cases of influenza-like illness from the canton of Bern from 473 of 497 municipalities (95.2%) were collected; the cases were registered between 30 June 1918 and 30 June 1919. The overall incidence rates of newly registered cases per week for the 9 greater regions of Bern for both the first and second waves of the pandemic were calculated. Relative incidence rate ratios (RIRRs) were calculated to estimate the change in the slope of incidence curves associated with public health interventions. During the first wave, school closures (RIRR, 0.16 [95% CI, 0.15 to 0.17]) and restrictions of mass gatherings (RIRR, 0.57 [CI, 0.54 to 0.61]) were associated with a deceleration of epidemic growth. During the second wave, in autumn 1918, cantonal authorities initially reacted hesitantly and delegated the responsibility to enact interventions to municipal authorities, which was associated with a lack of containment of the second wave. A premature relaxation of restrictions on mass gatherings was associated with a resurgence of the epidemic (RIRR, 1.18 [CI, 1.12 to 1.25]). Strikingly similar patterns were found in the management of the COVID-19 outbreak in Switzerland, with a considerably higher amplitude and prolonged duration of the second wave and much higher associated rates of hospitalization and mortality.

Comparison of Knowledge and Information-Seeking Behavior After General COVID-19 Public Health Messages and Messages Tailored for Black and Latinx Communities: A Randomized Controlled Trial: Annals of Internal Medicine: Vol 174, No 4

Background: The paucity of public health messages that directly address communities of color might contribute to racial and ethnic disparities in knowledge and behavior related to coronavirus disease 2019 (COVID-19). Objective: To determine whether physician-delivered prevention messages affect knowledge and information-seeking behavior of Black and Latinx individuals and whether this differs according to the race/ethnicity of the physician and tailored content. Design: Randomized controlled trial. (Registration: ClinicalTrials.gov, NCT04371419; American Economic Association RCT Registry, AEARCTR-0005789) Setting: United States, 13 May 2020 to 26 May 2020. Participants: 14 267 self-identified Black or Latinx adults recruited via Lucid survey platform. Intervention: Participants viewed 3 video messages regarding COVID-19 that varied by physician race/ethnicity, acknowledgment of racism/inequality, and community perceptions of mask wearing. Measurements: Knowledge gaps (number of errors on 7 facts on COVID-19 symptoms and prevention) and information-seeking behavior (number of web links demanded out of 10 proposed). Results: 7174 Black (61.3%) and 4520 Latinx (38.7%) participants were included in the analysis. The intervention reduced the knowledge gap incidence from 0.085 to 0.065 (incidence rate ratio [IRR], 0.737 [95% CI, 0.600 to 0.874]) but did not significantly change information-seeking incidence. For Black participants, messages from race/ethnicity-concordant physicians increased information-seeking incidence from 0.329 (for discordant physicians) to 0.357 (IRR, 1.085 [CI, 1.026 to 1.145]). Limitations: Participants' behavior was not directly observed, outcomes were measured immediately postintervention in May 2020, and online recruitment may not be representative. Conclusion: Physician-delivered messages increased knowledge of COVID-19 symptoms and prevention methods for Black and Latinx respondents. The desire for additional information increased with race-concordant messages for Black but not Latinx respondents. Other tailoring of the content did not make a significant difference. Primary Funding Source: National Science Foundation; Massachusetts General Hospital; and National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases.

COVID-19 Symptoms: Longitudinal Evolution and Persistence in Outpatient Settings

Should You Recommend Direct-to-Consumer Genetic Testing for This Patient?: Grand Rounds Discussion From Beth Israel Deaconess Medical Center: Annals of Internal Medicine: Vol 173, No 7

In recent years, the number of patients choosing to have direct-to-consumer (DTC) genetic testing without involving their clinicians has increased substantially. For example, the number of subscribers to a commonly used testing site has grown to more than 10 million. These services have been heavily marketed in the United States and often include information about ancestry; genetic traits; and, increasingly, disease risk. In clinical care, genetic testing by a physician is accompanied by both pre- and posttest counseling by a trained genetic counselor. However, there are not enough genetic counselors to meet the needs of all persons contemplating DTC genetic testing. Formal genetic counseling includes preparation of a family pedigree; a discussion about potential benefits, the possibility that some information might be stressful to receive or difficult to understand, and the potential for disclosure of genetic information; and a detailed informed consent process. Some DTC tests for genetic susceptibilities look for only a few known mutations in a particular gene (such as BRCA1); a negative test result does not exclude the possibility of a clinically important mutation. A positive DTC genetic test result that might change clinical management should be followed by a confirmatory test through a genetics laboratory. Here, 2 expert physicians—a general internist and a medical oncologist with genetics experience—discuss an approach to counseling a patient who is considering DTC testing to learn more about his ancestry and his risk for metabolic syndrome.

Risk for Severe COVID-19 Illness Among Teachers and Adults Living With School-Aged Children

Probability of Success and Timelines for the Development of Vaccines for Emerging and Reemerged Viral Infectious Diseases

Background: Anticipated success rates and timelines for COVID-19 vaccine development vary. Recent experience with developing and testing viral vaccine candidates can inform expectations regarding the development of safe and effective vaccines. Objective: To estimate timelines and probabilities of success for recent vaccine candidates. Design: ClinicalTrials.gov was searched to identify trials testing viral vaccines that had not advanced to phase 2 before 2005, and the progress of each vaccine from phase 1 through to U.S. Food and Drug Administration (FDA) licensure was tracked. Trial characteristics were double-coded. (Registration: Open Science Framework [https://osf.io/dmuzx/]) Setting: Trials launched between January 2005 and March 2020. Participants: Preventive viral vaccine candidates for 23 emerging or reemerged viral infectious diseases. Measurements: The primary end point was the probability of vaccines advancing from launch of phase 2 to FDA licensure within 10 years. Results: In total, 606 clinical trials forming 220 distinct development trajectories (267 343 enrolled participants) were identified. The probability of vaccines progressing from phase 2 to licensure within 10 years was 10.0% (95% CI, 2.6% to 16.9%), with most approvals representing H1N1 or H5N1 vaccines. The average timeline from phase 2 to approval was 4.4 years (range, 6.4 weeks to 13.9 years). The probabilities of advancing from phase 1 to 2, phase 2 to 3, and phase 3 to licensure within the total available follow-up time were 38.2% (CI, 30.7% to 45.0%), 38.3% (CI, 23.1% to 50.5%), and 61.1% (CI, 3.7% to 84.3%), respectively. Limitations: The study did not account for preclinical development and relied primarily on ClinicalTrials.gov and FDA resources. Success probabilities do not capture the varied reasons why vaccines fail to advance to regulatory approval. Conclusion: Success probabilities and timelines varied widely across different vaccine types and diseases. If a SARS-CoV-2 vaccine is licensed within 18 months of the start of the pandemic, it will mark an unprecedented achievement for noninfluenza viral vaccine development. Primary Funding Source: McGill Interdisciplinary Initiative in Infection and Immunity (MI4) Emergency COVID-19 Research Funding program.

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