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These Annals of Internal Medicine results only contain recent articles.

2018 Cholesterol Clinical Practice Guidelines: Synopsis of the 2018 American Heart Association/American College of Cardiology/Multisociety Cholesterol Guideline*

Description: In November 2018, the American Heart Association and American College of Cardiology (AHA/ACC) released a new clinical practice guideline on cholesterol management. It was accompanied by a risk assessment report on primary prevention of atherosclerotic cardiovascular disease (ASCVD). Methods: A panel of experts free of recent and relevant industry-related conflicts was chosen to carry out systematic reviews and meta-analyses of randomized controlled trials (RCTs) that examined cardiovascular outcomes. High-quality observational studies were used for estimation of ASCVD risk. An independent panel systematically reviewed RCT evidence about the benefits and risks of adding nonstatin medications to statin therapy compared with receiving statin therapy alone in persons who have or are at high risk for ASCVD. Recommendation: The guideline endorses a heart-healthy lifestyle beginning in childhood to reduce lifetime risk for ASCVD. It contains several new features compared with the 2013 guideline. For secondary prevention, patients at very high risk may be candidates for adding nonstatin medications (ezetimibe or proprotein convertase subtilisin/kexin type 9 [PCSK9] inhibitors) to statin therapy. In primary prevention, a clinician–patient risk discussion is still strongly recommended before a decision is made about statin treatment. The AHA/ACC risk calculator first triages patients into 4 risk categories. Those at intermediate risk deserve a focused clinician–patient discussion before initiation of statin therapy. Among intermediate-risk patients, identification of risk-enhancing factors and coronary artery calcium testing can assist in the decision to use a statin. Compared with the 2013 guideline, the new guideline gives more attention to percentage reduction in low-density lipoprotein cholesterol as a treatment goal and to long-term monitoring of therapeutic efficacy. To simplify monitoring, nonfasting lipid measurements are allowed.

Policy Recommendations for Pharmacy Benefit Managers to Stem the Escalating Costs of Prescription Drugs: A Position Paper From the American College of Physicians

Recent discussions about the increasing prices of prescription drugs have focused on pharmacy benefit managers (PBMs), third-party intermediaries for various types of employers and government purchasers who negotiate drug prices in health plans and thus play a crucial role in determining the amount millions of Americans pay for medications. In this position paper, the American College of Physicians expands on its position paper from 2016 by offering additional recommendations to improve transparency in the PBM industry and highlighting the need for reliable, timely, and relevant information on prescription drug pricing for physicians and patients.

Policy Recommendations for Public Health Plans to Stem the Escalating Costs of Prescription Drugs: A Position Paper From the American College of Physicians

The increasing price of prescription drugs is an ongoing concern for Medicare and Medicaid, particularly for patients with chronic health conditions who are using multiple medications and patients in these programs taking high-priced brand-name specialty drugs. Shifts in benefit design, including higher deductibles and a movement away from copayments to coinsurance, have increased patient out-of-pocket costs and put pressure on program budgets. In this paper, the American College of Physicians expands on its position paper from 2016 and offers additional recommendations to decrease out-of-pocket costs for patients, enhance the government's purchasing power, and address existing policies that add costs to the health care system.

The Development of Clinical Guidelines and Guidance Statements by the Clinical Guidelines Committee of the American College of Physicians: Update of Methods

The American College of Physicians (ACP) was one of the first organizations in the United States to develop evidence-based clinical guidelines and has been developing guidelines since 1981. ACP's Clinical Guidelines Committee (CGC), in collaboration with staff from the Clinical Policy department, develops clinical guidelines and guidance statements and continues to refine and enhance its methodology. This article presents an update of the CGC's 2010 paper outlining policies, methods, and presentation format of ACP's clinical guidelines and guidance statements. Updated methods include more stringent policies about disclosure of interests and conflict management; inclusion of public perspective; full adoption of GRADE (Grading of Recommendations Assessment, Development and Evaluation) methods; more standardized reporting formats that consider value of care, patient comorbid conditions, patient values and preferences, and costs; and further clarification of guidance statement methods.

Disclosure of Interests and Management of Conflicts of Interest in Clinical Guidelines and Guidance Statements: Methods From the Clinical Guidelines Committee of the American College of Physicians

One of the hallmarks of a trustworthy clinical guideline or guidance statement is a comprehensive process for disclosure of interests (DOI) and management of conflicts of interest (COIs). The American College of Physicians (ACP) Clinical Guidelines Committee (CGC) aims to disclose all health care–related interests and manage conflicts in a manner that is transparent, proportional, and consistent. Any person involved in the development of an ACP clinical guideline or guidance statement must disclose all financial and intellectual interests related to health care from the previous 3 years. Persons complete disclosures at the start of their participation and are required to update them over the course of their involvement with the CGC, including before each CGC meeting. A DOI-COI Review and Management Panel reviews the disclosures; flags potential conflicts; grades the COI as low-, moderate-, or high-level; and manages the person's participation accordingly. A high-level COI results in recusal from authorship, voting, and all committee discussions. Participants with a moderate-level COI are recused from authorship and voting for clinically relevant topics but may participate in all discussions. A low-level COI results in no role restrictions. All disclosures and COI management decisions are publicly reported.

Lack of Evidence Linking Calcium With or Without Vitamin D Supplementation to Cardiovascular Disease in Generally Healthy Adults: A Clinical Guideline From the National Osteoporosis Foundation and the American Society for Preventive Cardiology

Description: Calcium is the dominant mineral present in bone and a shortfall nutrient in the American diet. Supplements have been recommended for persons who do not consume adequate calcium from their diet as a standard strategy for the prevention of osteoporosis and related fractures. Whether calcium with or without vitamin D supplementation is beneficial or detrimental to vascular health is not known. Methods: The National Osteoporosis Foundation and American Society for Preventive Cardiology convened an expert panel to evaluate the effects of dietary and supplemental calcium on cardiovascular disease based on the existing peer-reviewed scientific literature. The panel considered the findings of the accompanying updated evidence report provided by an independent evidence review team at Tufts University. Recommendation: The National Osteoporosis Foundation and American Society for Preventive Cardiology adopt the position that there is moderate-quality evidence (B level) that calcium with or without vitamin D intake from food or supplements has no relationship (beneficial or harmful) to the risk for cardiovascular and cerebrovascular disease, mortality, or all-cause mortality in generally healthy adults at this time. In light of the evidence available to date, calcium intake from food and supplements that does not exceed the tolerable upper level of intake (defined by the National Academy of Medicine as 2000 to 2500 mg/d) should be considered safe from a cardiovascular standpoint.

Telemedicine Policy and Practice: A Position Paper From the American College of Physicians

In response to the COVID-19 pandemic, federal policymakers temporarily lifted long-standing restrictions on telemedicine, resulting in an unprecedented and rapid expansion of virtual care across video, audio, and asynchronous modalities. When integrated into longitudinal care relationships, telemedicine can increase access, reduce patient burden, and support continuity for people facing geographic, mobility, or socioeconomic barriers. However, telemedicine also introduces new clinical, regulatory, equity, and safety challenges that require deliberate policy design. Beyond its clinical considerations, telehealth offers environmental and logistical benefits, including reduced travel time and cost, decreased fuel consumption, lower transportation expenses, and lower greenhouse gas emissions. In this position paper, the American College of Physicians updates its previous policy paper on telemedicine to reflect changes in payment policy, licensure, prescribing authority, and utilization patterns that have occurred over the past decade and accelerated during the COVID-19 public health emergency. This paper focuses on access, payment policy, licensure, prescribing practices, equity, and patient safety across federal and state programs and private payers and emphasizes the conditions under which telemedicine should be integrated into clinical practice. Key developments addressed include the expansion and partial lapse of Medicare telemedicine waivers, evolving U.S. Drug Enforcement Administration rules governing prescribing, increased reliance on interstate practice, and normalization of telemedicine by private payers.

Principles of Managed Care: A Position Paper From the American College of Physicians

Most U.S. health plans use managed care strategies, including health care use management and clinician networks. Most Medicare, Medicaid, and commercial insurance enrollees are covered by managed care plans. Managed care is ostensibly used to steer patients toward high-quality clinicians and facilities and contain costs; however, prior authorization, narrow clinician networks, and other managed care strategies often restrict access to necessary care, causing frustration among patients and physicians. In this position paper, the American College of Physicians offers policy recommendations to protect patients from onerous managed care processes, reduce administrative burdens associated with managed care, and ensure that patients can promptly access high-value, medically necessary care.