Patient Centered Primary Care Collaborate Supports Don Berwick's Nomination to CMS

Adult Immunization Sign on letter

Support Appropriations for Primary Care Training and Enhancement Program

Safe Seniors Assurance Study Act of 1999 (S. 818/H.R. 632). Joint Letter to Health Care Financing Administration.

Restrictions to Use of the Tobacco Reserve Fund. Letter to Senate.

Letter on Resource Based Practice Expenses Payments

Resource-based Practice Expenses and Medicare Fee Schedule of 1997. Letter to Commerce Committee and House Ways and Means Committee, U.S. House of Representives, and Finance Committee, U.S. Senate.

Resource-based Practice Expenses for the Medicare Fee Schedule.

Resource-Based Practice Expenses, Medicare Fee Schedule

Resource-based Practice Expenses and Medicare Budget. Letter to Budget Conferees, U.S. House of Representatives.

Effects of State Opioid Prescribing Laws on Use of Opioid and Other Pain Treatments Among Commercially Insured U.S. Adults

Background: There is concern that state laws to curb opioid prescribing may adversely affect patients with chronic noncancer pain, but the laws' effects are unclear because of challenges in disentangling multiple laws implemented around the same time. Objective: To study the association between state opioid prescribing cap laws, pill mill laws, and mandatory prescription drug monitoring program query or enrollment laws and trends in opioid and guideline-concordant nonopioid pain treatment among commercially insured adults, including a subgroup with chronic noncancer pain conditions. Design: Thirteen treatment states that implemented a single law of interest in a 4-year period and unique groups of control states for each treatment state were identified. Augmented synthetic control analyses were used to estimate the association between each state law and outcomes. Setting: United States, 2008 to 2019. Patients: 7 694 514 commercially insured adults aged 18 years or older, including 1 976 355 diagnosed with arthritis, low back pain, headache, fibromyalgia, and/or neuropathic pain. Measurements: Proportion of patients receiving any opioid prescription or guideline-concordant nonopioid pain treatment per month, and mean days' supply and morphine milligram equivalents (MME) of prescribed opioids per day, per patient, per month. Results: Laws were associated with small-in-magnitude and non–statistically significant changes in outcomes, although CIs around some estimates were wide. For adults overall and those with chronic noncancer pain, the 13 state laws were each associated with a change of less than 1 percentage point in the proportion of patients receiving any opioid prescription and a change of less than 2 percentage points in the proportion receiving any guideline-concordant nonopioid treatment, per month. The laws were associated with a change of less than 1 in days' supply of opioid prescriptions and a change of less than 4 in average monthly MME per day per patient prescribed opioids. Limitations: Results may not be generalizable to non–commercially insured populations and were imprecise for some estimates. Use of claims data precluded assessment of the clinical appropriateness of pain treatments. Conclusion: This study did not identify changes in opioid prescribing or nonopioid pain treatment attributable to state laws. Primary Funding Source: National Institute on Drug Abuse.

A Reporting Tool for Adapted Guidelines in Health Care: The RIGHT-Ad@pt Checklist

Background: Adaptation of existing guidelines can be an efficient way to develop contextualized recommendations. Transparent reporting of the adaptation approach can support the transparency and usability of the adapted guidelines. Objective: To develop an extension of the RIGHT (Reporting Items for practice Guidelines in HealThcare) statement for the reporting of adapted guidelines (including recommendations that have been adopted, adapted, or developed de novo), the RIGHT-Ad@pt checklist. Design: A multistep process was followed to develop the checklist: establishing a working group, generating an initial checklist, optimizing the checklist (through an initial assessment of adapted guidelines, semistructured interviews, a Delphi consensus survey, an external review, and a final assessment of adapted guidelines), and approval of the final checklist by the working group. Setting: International collaboration. Participants: A total of 119 professionals participated in the development process. Measurements: Participants' consensus on items in the checklist. Results: The RIGHT-Ad@pt checklist contains 34 items grouped in 7 sections: basic information (7 items); scope (6 items); rigor of development (10 items); recommendations (4 items); external review and quality assurance (2 items); funding, declaration, and management of interest (2 items); and other information (3 items). A user guide with explanations and real-world examples for each item was developed to provide a better user experience. Limitation: The RIGHT-Ad@pt checklist requires further validation in real-life use. Conclusion: The RIGHT-Ad@pt checklist has been developed to improve the reporting of adapted guidelines, focusing on the standardization, rigor, and transparency of the process and the clarity and explicitness of adapted recommendations. Primary Funding Source: None.

The Management of Substance Use Disorders: Synopsis of the 2021 U.S. Department of Veterans Affairs and U.S. Department of Defense Clinical Practice Guideline

Description: In August 2021, leadership within the U.S. Department of Veterans Affairs (VA) and U.S. Department of Defense (DoD) approved a joint clinical practice guideline (CPG) for the management of substance use disorders (SUDs). This synopsis summarizes key recommendations. Methods: In March 2020, the VA/DoD Evidence-Based Practice Work Group assembled a team to update the 2015 VA/DoD Clinical Practice Guideline for the Management of Substance Use Disorders that included clinical stakeholders and conformed to the National Academy of Medicine's tenets for trustworthy CPGs. The guideline panel developed key questions, systematically searched and evaluated the literature, created two 1-page algorithms, and distilled 35 recommendations for care using the GRADE (Grading of Recommendations Assessment, Development and Evaluation) system. This synopsis presents the recommendations that were believed to be the most clinically impactful. Recommendations: The scope of the CPG is broad; however, this synopsis focuses on key recommendations for the management of alcohol use disorder, use of buprenorphine in opioid use disorder, contingency management, and use of technology and telehealth to manage patients remotely.

Getting Through COVID-19: Keeping Clinicians in the Workforce

Vitamin D Deficiency Increases Mortality Risk in the UK Biobank: A Nonlinear Mendelian Randomization Study: Annals of Internal Medicine: Vol 175, No 11

Background: Low vitamin D status is associated with increased mortality, but randomized trials on severely deficient participants are lacking. Objective: To assess genetic evidence for the causal role of low vitamin D status in mortality. Design: Nonlinear Mendelian randomization analyses. Setting: UK Biobank, a large-scale, prospective cohort from England, Scotland, and Wales with participants recruited between March 2006 and July 2010. Participants: 307 601 unrelated UK Biobank participants of White European ancestry (aged 37 to 73 years at recruitment) with available measurements of 25-hydroxyvitamin D (25-(OH)D) and genetic data. Measurements: Genetically predicted 25-(OH)D was estimated using 35 confirmed variants of 25-(OH)D. All-cause and cause-specific mortality (cardiovascular disease [CVD], cancer, and respiratory) were recorded up to June 2020. Results: There were 18 700 deaths during the 14 years of follow-up. The association of genetically predicted 25-(OH)D with all-cause mortality was L-shaped (P for nonlinearity < 0.001), and risk for death decreased steeply with increasing concentrations until 50 nmol/L. Evidence for an association was also seen in analyses of mortality from cancer, CVD, and respiratory diseases (P ≤ 0.033 for all outcomes). Odds of all-cause mortality in the genetic analysis were estimated to increase by 25% (odds ratio, 1.25 [95% CI, 1.16 to 1.35]) for participants with a measured 25-(OH)D concentration of 25 nmol/L compared with 50 nmol/L. Limitations: Analyses were restricted to a White European population. A genetic approach is best suited to providing proof of principle on causality, whereas the strength of the association is approximate. Conclusion: Our study supports a causal relationship between vitamin D deficiency and mortality. Additional research needs to identify strategies that meet the National Academy of Medicine's guideline of greater than 50 nmol/L and that reduce the premature risk for death associated with low vitamin D levels. Primary Funding Source: National Health and Medical Research Council.

Pregnancy Outcomes in Women With a Prior Cervical Intraepithelial Neoplasia Grade 3 Diagnosis: A Nationwide Population-Based Cohort Study With Sibling Comparison Design: Annals of Internal Medicine: Vol 175, No 2

Background: Treatment of cervical intraepithelial neoplasia grade 3 (CIN 3) removes or destroys part of the cervix and might subsequently influence pregnancy outcomes. Objective: To investigate pregnancy outcomes in women diagnosed with CIN 3. Design: Population- and sibling-matched cohort study. Setting: Sweden, 1973 to 2018. Participants: The general population comparison included 78 450 singletons born to women diagnosed with CIN 3 and 784 500 matched singletons born to women in the general population who had no CIN 3 diagnosis; the sibling comparison included 23 199 singletons born to women diagnosed with CIN 3 and 28 135 singletons born to their sisters without a CIN 3 diagnosis. Measurements: Preterm birth, including spontaneous or iatrogenic preterm birth; infection-related outcomes, including chorioamnionitis and infant sepsis; and early neonatal death, defined as death during the first week after birth. Results: Compared with the matched general population, women previously diagnosed with CIN 3 were more likely to have a preterm birth, especially extremely preterm (22 to 28 weeks; odds ratio [OR], 3.00 [95% CI, 2.69 to 3.34]) or spontaneous preterm (OR, 2.12 [CI, 2.05 to 2.20]); infection-related outcomes, including chorioamnionitis (OR, 3.23 [CI, 2.89 to 3.62]) and infant sepsis (OR, 1.72 [CI, 1.60 to 1.86]); or early neonatal death (OR, 1.83 [CI, 1.61 to 2.09]). Sibling comparison analyses rendered largely similar results. Over time, the risk difference attenuated for all outcomes and disappeared for early neonatal death. Limitation: Lack of data on CIN 3 treatment and spontaneous abortion. Conclusion: History of CIN 3 is associated with adverse pregnancy outcomes even after accounting for familial factors. Decreasing risk estimates over time suggest that adverse pregnancy outcomes among women diagnosed with CIN 3 may be minimized by improving treatment methods. Primary Funding Source: The Swedish Research Council, the Swedish Cancer Society, and the Swedish Research Council for Health, Working Life and Welfare.

Efficacy of Acupuncture for Chronic Prostatitis/Chronic Pelvic Pain Syndrome: A Randomized Trial: Annals of Internal Medicine: Vol 174, No 10

Background: Acupuncture has promising effects on chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS), but high-quality evidence is scarce. Objective: To assess the long-term efficacy of acupuncture for CP/CPPS. Design: Multicenter, randomized, sham-controlled trial. (ClinicalTrials.gov: NCT03213938) Setting: Ten tertiary hospitals in China. Participants: Men with moderate to severe CP/CPPS, regardless of prior exposure to acupuncture. Intervention: Twenty sessions of acupuncture or sham acupuncture over 8 weeks, with 24-week follow-up after treatment. Measurements: The primary outcome was the proportion of responders, defined as participants who achieved a clinically important reduction of at least 6 points from baseline on the National Institutes of Health Chronic Prostatitis Symptom Index at weeks 8 and 32. Ascertainment of sustained efficacy required the between-group difference to be statistically significant at both time points. Results: A total of 440 men (220 in each group) were recruited. At week 8, the proportions of responders were 60.6% (95% CI, 53.7% to 67.1%) in the acupuncture group and 36.8% (CI, 30.4% to 43.7%) in the sham acupuncture group (adjusted difference, 21.6 percentage points [CI, 12.8 to 30.4 percentage points]; adjusted odds ratio, 2.6 [CI, 1.8 to 4.0]; P < 0.001). At week 32, the proportions were 61.5% (CI, 54.5% to 68.1%) in the acupuncture group and 38.3% (CI, 31.7% to 45.4%) in the sham acupuncture group (adjusted difference, 21.1 percentage points [CI, 12.2 to 30.1 percentage points]; adjusted odds ratio, 2.6 [CI, 1.7 to 3.9]; P < 0.001). Twenty (9.1%) and 14 (6.4%) adverse events were reported in the acupuncture and sham acupuncture groups, respectively. No serious adverse events were reported. Limitation: Sham acupuncture might have had certain physiologic effects. Conclusion: Compared with sham therapy, 20 sessions of acupuncture over 8 weeks resulted in greater improvement in symptoms of moderate to severe CP/CPPS, with durable effects 24 weeks after treatment. Primary Funding Source: China Academy of Chinese Medical Sciences and the National Administration of Traditional Chinese Medicine.

Disparate Impact: How Colorblind Policies Exacerbate Black–White Health Inequities

Rivaroxaban Is Associated With Higher Rates of Gastrointestinal Bleeding Than Other Direct Oral Anticoagulants: A Nationwide Propensity Score–Weighted Study: Annals of Internal Medicine: Vol 174, No 11

Background: Gastrointestinal bleeding (GIB) rates for direct oral anticoagulants (DOACs) and warfarin have been extensively compared. However, population-based studies comparing GIB rates among different DOACs are limited. Objective: To compare rates of GIB among apixaban, dabigatran, and rivaroxaban. Design: Nationwide population-based cohort study. Setting: Landspítali–The National University Hospital of Iceland and the 4 regional hospitals in Iceland. Patients: New users of apixaban, dabigatran, and rivaroxaban from 2014 to 2019. Measurements: Rates of GIB were compared using inverse probability weighting, Kaplan–Meier survival estimates, and Cox regression. Results: In total, 2157 patients receiving apixaban, 494 patients receiving dabigatran, and 3217 patients receiving rivaroxaban were compared. For all patients, rivaroxaban had higher overall rates of GIB (3.2 vs. 2.5 events per 100 person-years; hazard ratio [HR], 1.42 [95% CI, 1.04 to 1.93]) and major GIB (1.9 vs. 1.4 events per 100 person-years; HR, 1.50 [CI, 1.00 to 2.24]) compared with apixaban. Rivaroxaban also had higher GIB rates than dabigatran, with similar point estimates, although the CIs were wider and included the possibility of a null effect. When only patients with atrial fibrillation were included, rivaroxaban was associated with higher rates of overall GIB than apixaban (HR, 1.40 [CI, 1.01 to 1.94]) or dabigatran (HR, 2.04 [CI, 1.17 to 3.55]). Dabigatran was associated with lower rates of upper GIB than rivaroxaban in both analyses. Limitations: Unmeasured confounding and small subgroup analyses. Conclusion: Rivaroxaban was associated with higher GIB rates than apixaban and dabigatran regardless of treatment indication. Primary Funding Source: Icelandic Centre for Research and Landspítali–The National University Hospital of Iceland.

Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV): Designing Master Protocols for Evaluation of Candidate COVID-19 Therapeutics

Working in an unprecedented time frame, the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) public–private partnership developed and launched 9 master protocols between 14 April 2020 and 31 May 2021 to allow for the coordinated and efficient evaluation of multiple investigational therapeutic agents for COVID-19. The ACTIV master protocols were designed with a portfolio approach to serve the following patient populations with COVID-19: mild to moderately ill outpatients, moderately ill inpatients, and critically ill inpatients. To facilitate the execution of these studies and minimize start-up time, ACTIV selected several existing networks to launch the master protocols. The master protocols were also designed to test several agent classes prioritized by ACTIV that covered the spectrum of the disease pathophysiology. Each protocol, either adaptive or pragmatic, was designed to efficiently select those treatments that provide benefit to patients while rapidly eliminating those that were either ineffective or unsafe. The ACTIV Therapeutics-Clinical Working Group members describe the process by which these master protocols were designed, developed, and launched. Lessons learned that may be useful in meeting the challenges of a future pandemic are also described.