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HHS OIG — Medicare’s Oversight of Compounded Pharmaceuticals Used in Hospitals

January 28, 2015 Comments off

Medicare’s Oversight of Compounded Pharmaceuticals Used in Hospitals
Source: U.S. Department of Health and Human Services, Office of Inspector General

WHY WE DID THIS STUDY
A 2012 nationwide meningitis outbreak caused by contaminated injections, which were produced by a standalone compounding pharmacy, raised concerns about compounded sterile preparations (CSPs). Subsequent OIG work found that almost all acute-care hospitals use CSPs and most contract with standalone compounding pharmacies to provide at least some of these products. CMS oversees the safety of CSPs prepared and used in Medicare-participating hospitals through the hospital certification process, in which State survey agencies or CMS-approved accreditors assess hospital compliance with requirements for drug compounding. This study provides information about the extent to which Medicare’s oversight of hospitals addresses recommended practices for CSPs. In 2013, Congress passed the Drug Quality and Security Act, which clarifies the Food and Drug Administration’s authority over standalone compounding pharmacies.

HOW WE DID THIS STUDY
We reviewed the practices of the five entities that oversee hospitals that participate in Medicare-namely, CMS and the four hospital accreditors approved by CMS. Through consultation with experts in CSP oversight, OIG identified 55 recommended practices for CSP oversight in acute-care hospitals. Representatives from each oversight entity participated in a structured interview and completed a questionnaire about how their respective surveys of hospitals incorporate these recommended practices. We analyzed the data from the interviews and the questionnaire to determine the extent to which Medicare’s oversight addresses recommended practices for CSP oversight.

WHAT WE FOUND
Oversight entities address most of the recommended CSP-related practices at least some of the time. However, only one oversight entity always reviews hospital contracts with standalone compounding pharmacies. Oversight entities may also lack the human capital required to thoroughly review hospitals’ preparation and use of CSPs. Surveyors receive limited training specific to compounding, and most oversight entities do not routinely include pharmacists on hospital surveys. Finally, although most oversight entities are considering changes to how they oversee hospitals’ preparation and use of CSPs, none of them are considering changes to how they oversee hospitals’ contracts with standalone compounding pharmacies.

WHAT WE RECOMMEND
CMS should (1) ensure that hospital surveyors receive training on standards from nationally recognized organizations related to safe compounding practices and (2) amend its interpretive guidelines to address hospitals’ contracts with standalone compounding pharmacies. CMS concurred with both recommendations.

Assisted Reproductive Technology Surveillance — United States, 2011

January 27, 2015 Comments off

Assisted Reproductive Technology Surveillance — United States, 2011
Source: Morbidity and Mortality Weekly Report (CDC)

In 2011, a total of 151,923 ART procedures performed in 451 U.S. fertility clinics were reported to CDC. These procedures resulted in 47,818 live-birth deliveries and 61,610 infants. The largest numbers of ART procedures were performed among residents of six states: California (18,808), New York (excluding New York City) (14,576), Massachusetts (10,106), Illinois (9,886), Texas (9,576), and New Jersey (8,698). These six states also had the highest number of live-birth deliveries as a result of ART procedures and together accounted for 47.2% of all ART procedures performed, 45.3% of all infants born from ART, and 45.1% of all multiple live-birth deliveries, but only 34% of all infants born in the United States. Nationally, the average number of ART procedures performed per 1 million women of reproductive age (15–44 years), which is a proxy indicator of ART use, was 2,401. In 11 states (Connecticut, Delaware, Hawaii, Illinois, Maryland, Massachusetts, New Hampshire, New Jersey, New York, Rhode Island, and Virginia), the District of Columbia, and New York City, this proxy measure was higher than the national rate, and of these, in three states (Massachusetts, New Jersey, and New York) and the District of Columbia, it exceeded twice the national rate. Nationally, among ART cycles with patients using fresh embryos from their own eggs in which at least one embryo was transferred, the average number of embryos transferred increased with increasing age (2.0 among women aged 40 years). Elective single-embryo transfer (eSET) rates decreased with increasing age (12.2% among women aged 40 years). Rates of eSET also varied substantially between states (range: 0.7% in Idaho to 53% in Delaware among women aged <35 years).

See also: Births Resulting From Assisted Reproductive Technology: Comparing Birth Certificate and National ART Surveillance System Data, 2011 (PDF; National Center for Health Statistics)

Review and Expunction of Central Registries and Reporting Records

January 26, 2015 Comments off

Review and Expunction of Central Registries and Reporting Records
Source: Child Welfare Information Gateway

This publication examines State laws and procedures that provide persons who are named as alleged perpetrators in central registry reports the right to review the records and to request administrative hearings to contest the findings and have inaccurate records removed from the registry. Laws that provide for the expunction of old or unsubstantiated reports also are discussed.

See also:
+ Making and Screening Reports of Child Abuse and Neglect (State Statutes)
+ Definitions of Child Abuse and Neglect (State Statutes)
+ Disclosure of Confidential Child Abuse and Neglect Records (State Statutes)
+ Establishment and Maintenance of Central Registries for Child Abuse Reports (State Statutes)

Also available: State Statutes Search

Diabetes Self-Management Education and Training Among Privately Insured Persons with Newly Diagnosed Diabetes — United States, 2011–2012

January 25, 2015 Comments off

Diabetes Self-Management Education and Training Among Privately Insured Persons with Newly Diagnosed Diabetes — United States, 2011–2012
Source: Morbidity and Mortality Weekly Report (CDC)

Diabetes is a complex chronic disease that requires active involvement of patients in its management (1). Diabetes self-management education and training (DSMT), “the ongoing process of facilitating the knowledge, skill, and ability necessary for prediabetes and diabetes self-care,” is an important component of integrated diabetes care (2). It is an intervention in which patients learn about diabetes and how to implement the self-management that is imperative to control the disease. The curriculum of DSMT often includes the diabetes disease process and treatment options; healthy lifestyle; blood glucose monitoring; preventing, detecting and treating diabetes complications; and developing personalized strategies for decision making (2). The American Diabetes Association recommends providing DSMT to those with newly diagnosed diabetes (1), because data suggest that when diabetes is first diagnosed is the time when patients are most receptive to such engagement (3). However, little is known about the proportion of persons with newly diagnosed diabetes participating in DSMT. CDC analyzed data from the Marketscan Commercial Claims and Encounters database (Truven Health Analytics) for the period 2009–2012 to estimate the claim-based proportion of privately insured adults (aged 18–64 years) with newly diagnosed diabetes who participated in DSMT during the first year after diagnosis. During 2011–2012, an estimated 6.8% of privately insured, newly diagnosed adults participated in DSMT during the first year after diagnosis of diabetes. These data suggest that there is a large gap between the recommended guideline and current practice, and that there is both an opportunity and a need to enhance rates of DSMT participation among persons newly diagnosed with diabetes.

Opioid Prescription Claims Among Women of Reproductive Age — United States, 2008–2012

January 23, 2015 Comments off

Opioid Prescription Claims Among Women of Reproductive Age — United States, 2008–2012
Source: Morbidity and Mortality Weekly Report (CDC)

Prescription opioid use in the United States has become widespread (1), and studies of opioid exposure in pregnancy suggest increased risk for adverse pregnancy outcomes, including neonatal abstinence syndrome and birth defects (e.g., neural tube defects, gastroschisis, and congenital heart defects) (2,3). The development of birth defects often results from exposures during the first few weeks of pregnancy, which is a critical period for organ formation. Given that many pregnancies are not recognized until well after the first few weeks and half of all U.S. pregnancies are unplanned (4), all women who might become pregnant are at risk. Therefore, it is important to assess opioid medication use among all women of reproductive age. CDC used Truven Health’s MarketScan Commercial Claims and Encounters and Medicaid data* to estimate the number of opioid prescriptions dispensed by outpatient pharmacies to women aged 15–44 years. During 2008–2012, opioid prescription claims were consistently higher among Medicaid-enrolled women when compared with privately insured women (39.4% compared with 27.7%, p<0.001). The most frequently prescribed opioids among women in both groups were hydrocodone, codeine, and oxycodone. Efforts are needed to promote interventions to reduce opioid prescriptions among this population when safer alternative treatments are available.

Vital Signs: HIV Diagnosis, Care, and Treatment Among Persons Living with HIV — United States, 2011

January 22, 2015 Comments off

Vital Signs: HIV Diagnosis, Care, and Treatment Among Persons Living with HIV — United States, 2011
Source: Morbidity and Mortality Weekly Report (CDC)

Background:
Infection with human immunodeficiency virus (HIV), if untreated, leads to acquired immunodeficiency syndrome (AIDS) and premature death. However, a continuum of services including HIV testing, HIV medical care, and antiretroviral therapy (ART) can lead to viral suppression, improved health and survival of persons infected with HIV, and prevention of HIV transmission.

Methods:
CDC used data from the National HIV Surveillance System and the Medical Monitoring Project to estimate the percentages of persons living with HIV infection, diagnosed with HIV infection, linked to HIV medical care, engaged in HIV medical care, prescribed ART, and virally suppressed in the United States during 2011.

Results:
In 2011, an estimated 1.2 million persons were living with HIV infection in the United States; an estimated 86% were diagnosed with HIV, 40% were engaged in HIV medical care, 37% were prescribed ART, and 30% achieved viral suppression. The prevalence of viral suppression was significantly lower among persons aged 18–24 years (13%), 25–34 years (23%), and 35–44 years (27%) compared with those aged ≥65 years (37%).

Conclusions:
A comprehensive continuum of services is needed to ensure that all persons living with HIV infection receive the HIV care and treatment needed to achieve viral suppression. Improvements are needed across the HIV care continuum to protect the health of persons living with HIV, reduce HIV transmission, and reach prevention and care goals.

Implications for public health practice:
State and local health departments, community-based organizations, and health care providers play essential roles in improving outcomes on the HIV care continuum that increase survival among persons living with HIV and prevent new HIV infections. The greatest opportunities for increasing the percentage of persons with a suppressed viral load are reducing undiagnosed HIV infections and increasing the percentage of persons living with HIV who are engaged in care.

Hospitalizations for Patients Aged 85 and Over in the United States, 2000–2010

January 21, 2015 Comments off

Hospitalizations for Patients Aged 85 and Over in the United States, 2000–2010
Source: National Center for Health Statistics

Key findings
Data from the National Hospital Discharge Survey

  • In 2010, adults aged 85 and over accounted for only 2% of the U.S. population but 9% of hospital discharges.
  • From 2000 through 2010, the rate of hospitalizations for adults aged 85 and over declined from 605 to 553 hospitalizations per 1,000 population, a 9% decrease.
  • The rate of fractures and other injuries was higher for adults aged 85 and over (51 per 1,000 population) than for adults aged 65–74 (9 per 1,000 population) and 75–84 (23 per 1,000 population).
  • Adults aged 85 and over were less likely than those aged 65–74 and 75–84 to be discharged home and more likely to die in the hospital.

From 2000 through 2010, the number of adults aged 85 and over in the United States rose 31%, from 4.2 million to 5.5 million, and in 2010, this age group represented almost 14% of the population aged 65 and over (1). It is estimated that by 2050, more than 21% of adults over age 65 will be aged 85 and over (2). Given this increase, adults aged 85 and over are likely to account for an increasing share of hospital utilization and costs in the coming years (3). This report describes hospitalizations for adults aged 85 and over with comparisons to adults aged 65–74 and 75–84.

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