ACP Letter of Support for S. 1016, the CONNECT for Health Act

ACP’s Letter Underscoring Concerns with the Equitable Community Access to Pharmacist Services Act

ACP Letter to the Ways and Means Committee with Recommendations for FY2022 Budget Reconciliation

ACP Comment Letter on 2020 Medicare Physician Fee Schedule Final Rule

Joint ACO Working Group Letter on Senate Finance Committee Chronic Care Policy Options

Mitigating the Negative Impact of Step Therapy Policies and Nonmedical Switching of Prescription Drugs on Patient Safety: An ACP Position Paper

ACP Comment Letter to CMS Regarding the Physician Fee Schedule Final Rule for CY 2016

ACP Comments on 2024 Physician Fee Schedule and Quality Payment Program Final Rule

ACP Comments on 2023 Physician Fee Schedule and Quality Payment Program Proposed Rule

ACP Comment Letter on Senate Finance Committee Chronic Care Policy Options

Key Evidence Supporting Prescription Opioids Approved by the U.S. Food and Drug Administration, 1997 to 2018

Background: Little is known about the evidence required by the U.S. Food and Drug Administration (FDA) for new approvals of opioid analgesics. Objective: To characterize the quality of safety and efficacy data in new drug applications (NDAs) for opioid analgesics approved by the FDA between 1997 and 2018. Design: Cross-sectional analysis. Setting: Data from ClinicalTrials.gov, FDA reviews, and peer-reviewed publications. Participants: Patients with pain who participated in phase 3 pivotal trials. Intervention: FDA-approved opioid analgesics. Measurements: Key characteristics of each NDA, including the number, size, and duration of pivotal trials; trial control groups; the use of enriched trial populations; and systematically measured safety outcomes. Results: Most of the 48 NDAs evaluated were for new dosage forms (n = 25 [52.1%]) or new formulations (n = 9 [18.8%]); only 1 (2.1%) was for a new molecular entity. Of 39 NDAs approved for treating chronic pain, only 21 products were supported by at least 1 pivotal trial; these trials (n = 28) had a median duration of 84 days (interquartile range [IQR], 25 to 84 days) and enrolled a median of 299 patients (IQR, 174 to 525 patients). Seventeen (81%) of these products were approved on the basis of designs that excluded patients who could not tolerate the drugs, had early adverse effects, or reported few immediate benefits. Among NDAs for chronic pain, 8 (20.5%) included pooled safety reviews that reported systematic assessment of diversion, 7 (17.9%) reported systematic measurement of nonmedical use, and 15 (38.5%) assessed development of tolerance. Eight of 9 products for acute pain were supported by at least 1 pivotal trial; the pivotal trials (n = 19) had a median duration of 1 day (IQR, 1 to 2 days) and enrolled a median of 329 patients (IQR, 199 to 456 patients). Although all but 1 of the 48 approved NDAs were for previously approved moieties, analysis of available NDAs for referent products yielded similar findings. Limitations: The analysis was limited to approved opioids. Animal studies and nonpivotal trials were excluded. Evidence for safety in NDAs was presented for chronic pain only. Conclusion: Between 1997 and 2018, the FDA approved opioids on the basis of pivotal trials of short or intermediate duration, often in narrowly defined pain populations of patients who could tolerate the drug. Systematic collation of certain important safety outcomes was rare. Primary Funding Source: None.

Factors Influencing Physician Practices' Adoption of Behavioral Health Integration in the United States: A Qualitative Study: Annals of Internal Medicine: Vol 173, No 2

Background: Behavioral health integration is uncommon among U.S. physician practices despite recent policy changes that may encourage its adoption. Objective: To describe factors influencing physician practices' implementation of behavioral health integration. Design: Semistructured interviews with leaders and clinicians from physician practices that adopted behavioral health integration, supplemented by contextual interviews with experts and vendors in behavioral health integration. Setting: 30 physician practices, sampled for diversity on specialty, size, affiliation with parent organizations, geographic location, and behavioral health integration model (collaborative or co-located). Participants: 47 physician practice leaders and clinicians, 20 experts, and 5 vendors. Measurements: Qualitative analysis (cyclical coding) of interview transcripts. Results: Four overarching factors affecting physician practices' implementation of behavioral health integration were identified. First, practices' motivations for integrating behavioral health care included expanding access to behavioral health services, improving other clinicians' abilities to respond to patients' behavioral health needs, and enhancing practice reputation. Second, practices tailored their implementation of behavioral health integration to local resources, financial incentives, and patient populations. Third, barriers to behavioral health integration included cultural differences and incomplete information flow between behavioral and nonbehavioral health clinicians and billing difficulties. Fourth, practices described the advantages and disadvantages of both fee-for-service and alternative payment models, and few reported positive financial returns. Limitation: The practice sample was not nationally representative and excluded practices that did not implement or sustain behavioral health integration, potentially limiting generalizability. Conclusion: Practices currently using behavioral health integration face cultural, informational, and financial barriers to implementing and sustaining behavioral health integration. Tailored, context-specific technical support to guide practices' implementation and payment models that improve the business case for practices may enhance the dissemination and long-term sustainability of behavioral health integration. Primary Funding Source: American Medical Association and The Commonwealth Fund.

Caring for the Transgender Patient: Grand Rounds Discussion From Beth Israel Deaconess Medical Center: Annals of Internal Medicine: Vol 172, No 3

The term transgender refers to persons whose gender identity is different from that recorded at birth. Similar to other marginalized populations, transgender patients commonly experience discrimination in the health care setting, and they may not have access to medical professionals who can provide competent care. In addition to primary medical and preventive health care, transgender patients need access to gender-affirming interventions, including hormone therapy and surgeries. In 2017, the Endocrine Society updated its clinical practice guideline for the care of transgender persons on the basis of the best available evidence from systematic reviews and individual studies. Among its general requirements for adolescents and recommendations for adults were the following: Involvement of a mental health professional who is knowledgeable about the diagnostic criteria for gender dysphoria and criteria for gender-affirming treatment, has training and experience in assessing psychopathology, and is willing to participate in ongoing care. Hormone therapy should be offered to transgender adult patients, with levels maintained within the normal range for gender identity and treatment appropriately monitored. Clinicians involved in the care of transgender adult patients should be knowledgeable about diagnostic criteria for gender dysphoria/gender incongruence, the use of medical and surgical gender-affirming interventions, and appropriate monitoring for reproductive organ cancer risk. Here, 2 clinicians with expertise in this area debate whether psychological evaluation is warranted in a transgender patient requesting gender-affirming hormones or surgery, the potential risks and benefits of estrogen therapy, and the role of the primary care practitioner in the care of transgender persons.

Predictors of Prolonged Opioid Use After Initial Prescription for Acute Musculoskeletal Injuries in Adults: A Systematic Review and Meta-analysis of Observational Studies: Annals of Internal Medicine: Vol 173, No 9

Background: Opioids are frequently prescribed for acute musculoskeletal injuries and may result in long-term use and consequent harms. Purpose: To explore factors associated with persistent opioid use after its prescription for acute musculoskeletal injury. Data Sources: Searches of multiple electronic databases, without language restrictions, from inception to 6 January 2020, and reference lists of selected articles. Study Selection: Observational studies of adults with opioid prescriptions for outpatient acute musculoskeletal injuries, in an adjusted model, that explored risk factors for prolonged use. Data Extraction: 6 reviewers, working in pairs, independently extracted data, rated the quality of studies, and evaluated the certainty of evidence. Data Synthesis: 14 cohorts with 13 263 393 participants were included. The overall prevalence of prolonged opioid use after musculoskeletal injury for high-risk populations (that is, patients receiving workers' compensation benefits, Veterans Affairs claimants, or patients with high rates of concurrent substance use disorder) was 27% (95% CI, 18% to 37%). The prevalence among low-risk populations was 6% (CI, 4% to 8%; P for interaction < 0.001). Moderate-certainty evidence showed increased odds of persistent opioid use with older age (absolute risk increase [ARI] for every 10-year increase, 1.1% [CI, 0.7% to 1.5%]) and physical comorbidity (ARI, 0.9% [CI, 0.1% to 1.7%]). Low-certainty evidence suggested increased risk for persistent opioid use with past or current substance use disorder (ARI, 10.5% [CI, 4.2% to 19.8%]), prescriptions lasting more than 7 days (median ARI, 4.5%), and higher morphine milligram equivalents per day. Limitation: Sparse, heterogeneous data with suboptimal adjustment for potential confounders. Conclusion: Avoiding prescribing opioids for acute musculoskeletal injuries to patients with past or current substance use disorder, and restricting duration to 7 days or less and using lower doses when they are prescribed, are potentially important targets to reduce rates of persistent opioid use. Primary Funding Source: National Safety Council. (PROSPERO: CRD42018104968)

Annals Clinical Decision Making: Incorporating Perspective Into Clinical Decisions

Who Owns Sepsis?

An Emerging Crisis: Vaping-Associated Pulmonary Injury

Health Care Administrative Costs in the United States and Canada, 2017

Background: Before Canada's single-payer reform, its payment system, health costs, and number of health administrative personnel per capita resembled those of the United States. By 1999, administration accounted for 31% of U.S. health expenditures versus 16.7% in Canada. No recent comprehensive analyses of those costs are available. Objective: To quantify 2017 spending for administration by insurers and providers. Design: Analyses of government reports, accounting data that providers file with regulators, surveys of physicians, and census-collected data on employment in health care. Setting: United States and Canada. Measurements: Insurance overhead; administrative expenditures of hospitals, physicians, nursing homes, home care agencies, and hospices. Results: U.S. insurers and providers spent $812 billion on administration, amounting to $2497 per capita (34.2% of national health expenditures) versus $551 per capita (17.0%) in Canada: $844 versus $146 on insurers' overhead; $933 versus $196 for hospital administration; $255 versus $123 for nursing home, home care, and hospice administration; and $465 versus $87 for physicians' insurance-related costs. Of the 3.2–percentage point increase in administration's share of U.S. health expenditures since 1999, 2.4 percentage points was due to growth in private insurers' overhead, mostly because of high overhead in their Medicare and Medicaid managed-care plans. Limitations: Estimates exclude dentists, pharmacies, and some other providers; accounting categories for the 2 countries differ somewhat; and methodological changes probably resulted in an underestimate of administrative cost growth since 1999. Conclusion: The gap in health administrative spending between the United States and Canada is large and widening, and it apparently reflects the inefficiencies of the U.S. private insurance–based, multipayer system. The prices that U.S. medical providers charge incorporate a hidden surcharge to cover their costly administrative burden. Primary Funding Source: None.

Rise Up

Declining Use of Primary Care Among Commercially Insured Adults in the United States, 2008–2016

Background: Primary care is known to improve outcomes and lower health care costs, prompting recent U.S. policy efforts to expand its role. Nonetheless, there is early evidence of a decline in per capita primary care visit rates, and little is understood about what is contributing to the decline. Objective: To describe primary care provider (PCP) visit trends among adults enrolled with a large, national, commercial insurer and assess factors underlying a potential decline in PCP visits. Design: Descriptive repeated cross-sectional study using 100% deidentified claims data from the insurer, 2008–2016. A 5% claims sample was used for Poisson regression models to quantify visit trends. Setting: National, population-based. Participants: Adult health plan members aged 18 to 64 years. Measurements: PCP visit rates per 100 member-years. Results: In total, 142 million primary care visits among 94 million member-years were examined. Visits to PCPs declined by 24.2%, from 169.5 to 134.3 visits per 100 member-years, while the proportion of adults with no PCP visits in a given year rose from 38.1% to 46.4%. Rates of visits addressing low-acuity conditions decreased by 47.7% (95% CI, −48.1% to −47.3%). The decline was largest among the youngest adults (−27.6% [CI, −28.2% to −27.1%]), those without chronic conditions (−26.4% [CI, −26.7% to −26.1%]), and those living in the lowest-income areas (−31.4% [CI, −31.8% to −30.9%]). Out-of-pocket cost per problem-based visit rose by $9.4 (31.5%). Visit rates to specialists remained stable (−0.08% [CI, −0.56% to 0.40%]), and visits to alternative venues, such as urgent care clinics, increased by 46.9% (CI, 45.8% to 48.1%). Limitation: Data were limited to a single commercial insurer and did not capture nonbilled clinician–patient interactions. Conclusion: Commercially insured adults have been visiting PCPs less often, and nearly one half had no PCP visits in a given year by 2016. Our results suggest that this decline may be explained by decreased real or perceived visit needs, financial deterrents, and use of alternative sources of care. Primary Funding Source: None.