In The News

New From AHRQ - Be Prepared to be Engaged: A Patient-Based Intervention Strategy for Primary Care

Patients and their families who arrive well-prepared to primary care visits are more likely to have important questions and concerns addressed by their health care team. Evidence suggests that engaging patients and families in discussions about their care leads to significant improvements in patient safety, care quality and patient experience. AHRQ’s new Be Prepared to be Engaged strategy, part of the agency’s Guide to Improving Patient Safety in Primary Care Settings by Engaging Patients and Families, features strategies for patients to prepare for primary care visits and improve the likelihood of leaving their visit with an understanding of their diagnosis and care plan, all of which can improve patient safety.

AHRQ Funding Opportunity:  Developing Measures of Shared Decision Making (R01)

A new funding opportunity announcement from AHRQ solicits applications for research projects to develop, test and evaluate measures of shared decision making for research conducted in clinical settings. Shared decision making is a collaborative process in which patients and members of their clinical team make health care decisions that are informed by scientific evidence as well as patients’ values and preferences. Each project is expected to produce valid and reliable measures of shared decision making, along with instructions for implementing the measures, as well as documentation on the development, testing and evaluation of the measures. Maximum costs for each project are $500,000 per year and $1.5 million for entire project periods up to three years.

AHRQ Publications Summarize Evidence on Behavioral Programs for Types 1 & 2 Diabetes

New publications from AHRQ summarize the effectiveness of behavioral programs to supplement clinical care for people with type 1 and type 2 diabetes, conditions that affect about 29 million Americans. The publications, developed for clinicians and consumers, reflect findings of an AHRQ-funded systematic review that examined behavioral programs for diabetes self-management including patient education, dietary interventions and structured exercise or physical activity interventions. Findings show, for example, that people with type 1 diabetes who participated in behavioral programs had greater reductions in hemoglobin A1C levels at 6 months, but that more research is needed to know if reductions can be sustained for 12 months or longer. For people with type 2 diabetes, 11 or more hours of behavioral programs resulted in improvements in glycemic control. AHRQ’s new online publications for clinicians summarize the effectiveness of behavioral programs and indicate the strength of evidence behind the findings:

Summaries for patients are written in plain language:

Call (800) 358-9295 or email AHRQPubs@ahrq.hhs.gov for printed versions of the patient publications.

New AHRQ Publications Summarize Evidence on Treating Low Back Pain

New evidence-based publications from AHRQ can help clinicians, patients and their families make informed decisions about treating low back pain, a condition that affects eight out of 10 people at least once in their lifetimes. Noninvasive Treatments for Low Back Pain: Current State of the Evidence is a clinician publication that summarizes the benefits and harms of noninvasive treatments for acute, subacute and chronic low back pain.

The publication summarizes findings in an AHRQ-funded systematic review that examined interventions including exercise, medications, acupuncture and superficial heat. The clinician publication also evaluates the strength of evidence for each finding. Also available is a new continuing education module based on the evidence review, as well as a plain-language publication for patients, Noninvasive Treatments for Low Back Pain – A Summary of the Research for Adults.

End-of-life care options for people with Alzheimer’s

Caring for someone in the final stage of life is always hard. It may be even harder when the person has Alzheimer’s disease.

Palliative care and hospice services provide care for a very ill person to keep him or her as comfortable and as pain-free as possible. Palliative care provides comfort care, along with any medical treatments a person might be receiving for a life-threatening illness. When a person is near the end of life, hospice care gives family members needed support and help with their grief, both before and after the person with Alzheimer’s dies.

What else can you do as a caregiver? Try making connections through senses like hearing, touch, or sight to bring comfort to the person with Alzheimer’s disease. Being touched or massaged and listening to music, “white” noise, or sounds from nature seem to soothe some people and lessen their agitation.

Learn more about end-of-life care and Alzheimer’s disease.

Final Recommendation Statement: Statin Use for the Primary Prevention of Cardiovascular Disease in Adults

The U.S. Preventive Services Task Force released today a final recommendation statement on statin use for the primary prevention of cardiovascular disease in adults. The Task Force found that statin use is beneficial for some people ages 40 to 75 years who are at increased risk for cardiovascular disease, but did not find enough evidence to recommend for or against statin use for people older than age 75 years. To view the recommendation and the evidence on which it is based, please go to http://www.uspreventiveservicestaskforce.org/Page/Document/UpdateSummaryFinal/statin-use-in-adults-preventive-medication1. The final recommendation statement can also be found in the November 13, 2016 online issue of JAMA.

Wyden Releases Report on Dangers of Underfunding Opioid Abuse

Earlier this year, Congress passed the Comprehensive Addiction and Recovery Act of 2016(CARA), but did not authorize funds for the policies it created. Shortly after that, the White House requested $920 million that would expand access to treatment in states as part of a larger effort to combat the opioid epidemic – Congress has not acted on that request.

Since passing CARA, Congressional Democrats have expressed concern surrounding the lack of funding to the policies the bill authorized. Senate Democrats, including Sen. Wyden, expressed frustration when only $7 million was provided in the legislation after efforts to produce an amendment that would deliver offsets to cover the full funding request.

On October 12, 2016, Senator Ron Wyden released a report that outlines the consequences of underfunding treatment for opioid addiction. According to Senator Wyden, “Congress’ approach to funding opioid addiction treatment is nothing short of legislative malpractice. There is bipartisan agreement that the opioid epidemic has to be confronted now. Yet, with dozens of Americans dying from an opioid overdose every day, Congress is breaking its promise to families around the country by not providing every resource available. The time for a ‘down payment’ has long passed.”

In his press release announcing the report, Senator Wyden referred to a study published by the Journal of American Medicine that showed nearly eighty percent of Americans suffering from opioid addiction are unable to access the treatment they need, especially in rural areas across the country.

Senator Wyden, who represents constituents in Oregon, stated,

“Sadly, Oregonians are no strangers to the human toll of drug use and addiction devastating families and communities. I’m extremely disheartened that Congress has closed up shop yet again without acting on its core promise to provide essential funding for proven opioid addiction treatment and prevention efforts. Until states receive real investments in these programs, Congress has failed its job. Families in Oregon and across the country deserve far better.”

Sen. Wyden’s report addresses two key challenges: (1) the lack of available treatment facilities and services across the country, and (2) the barriers patients face when treatment facilities or services are actually available. Additionally, the report details case studies in five states struggling with high rates of opioid addiction, including Wyden’s home state of Oregon, California, Ohio, Pennsylvania, and New Hampshire.

The report notes that “states are doing all they can to fight the epidemic, but as it stands now they do not have the money to build that capacity.” It then issues a call to action for Congress – “It is time for Congress to act. Every day Congress does not do so, another 78 people die waiting for someone to answer their call for help.”

According to Senator Wyden, if the requested funding were provided, it would help states like Oregon battle the opioid epidemic, by allowing them to establish additional treatment centers, to provide life-saving anti-overdose medication, and to train medical personnel to increase the number of those being treated.

The report includes appendices, which provide for a detailed breakdown of how much each state would receive under President Obama’s $920 million proposal; a justification of how the $920 million will be used, including eligible activities; and a summary of a Centers for Disease Control and Prevention (CDC) report, “Increases in Drug and Opioid Overdose Deaths – United States, 2000-2014”. At the end of the report is a lengthy list of footnotes, which provide additional reading for interested parties.

Pushing for additional federal money to go towards combating the opioid epidemic has been a top issue for Democrats in political office. When Congress comes back to work, and a new president elected, it is more likely than not this issue will rear its head once again.

Data Driven Enforcement - Risks of Open Payments and Medicare Part D Data

On Monday, November 14th, 2016, qordata is hosting a webinar on the topic, ‘Data Driven Enforcement – Risks of Open Payments and Medicare Part D Data’ at 11am CST. The webinar aims to provide a review of the cases against Insys Therapeutics Inc., and analyze the data that prosecutors used as part of the allegations against the manufacturer. The speakers of the webinar, Brian A. Dahl, Principal, Dahl Compliance Consulting LLC, and Mohammad Ovais, Founder & CEO, qordata, will also discuss the ways in which compliance teams can analyze publicly available Open Payments and Medicare Part D data to avoid risks of kickback violations.

The webinar hopes to provide attendees with a working knowledge of: how to analyze spend data from Open Payments and prescriptions from Medicare Part D to highlight certain high risk physicians, some key similarities in high risk physicians that compliance should be aware of and stay on top of, and information on how to reduce compliance risks within your organization.

Agenda

The webinar will start with a review of the cases filed against Insys Therapeutics Inc., and how publicly available Open Payments and Medicare Part D was used by investigators to place allegations on the manufacturer. From there, the discussion will turn to the importance of and how manufacturers can evaluate their spend data prior to CMS submission and how high risk physicians can be identified using spend and prescription data.

Speakers

Attendees of the webinar will get to hear from Brian A. Dahl, Principal, Dahl Compliance Consulting LLC, and Mohammad Ovais, Founder & CEO, qordata.

Registration

We encourage our readers to consider attending, as Chief Compliance Officers, Directors of Compliance, Managers of Compliance, Compliance Analysts, and Compliance Specialists, among others, have the potential to greatly benefit from this webinar. If you are interested in the webinar, you can register for free HERE.

Quality Measures Endorsed for Various Areas of Care

Friday, October 28, 2016

The National Quality Forum (NQF) has endorsed measures in the areas of cancer, palliative and end-of-life care, perinatal and reproductive health, and person- and family-centered care.

Cancer

NQF has endorsed 15 measures related to cancer care. The measures focus on breast cancer screening, appropriate treatment of breast, colon and prostate cancer, hematology, and febrile neutropenia. In all, 18 measures were evaluated against NQF’s endorsement criteria. Thirteen of these measures received endorsement status and two received inactive endorsement with reserve status. Three of the 18 reviewed measures were newly submitted measures and 15 were maintenance measures. For a complete list of measures, see the Cancer 2015-2017 project page.

Palliative and End-of-Life Care

NQF has endorsed 23 measures related to palliative and end-of-life care. The measures focus on physical, spiritual, religious, existential, ethical, and legal aspects of care, as well as care of the patient at the end of life. In all, 24 measures were evaluated against NQF’s endorsement criteria and 23 received endorsement status. Eight of the 24 reviewed measures were newly submitted measures and 16 were maintenance measures. For a complete list of measures, see the Palliative and End-of-Life Care 2015-2016 project page.

Perinatal and Reproductive Health

NQF has endorsed 18 measures related to perinatal and reproductive health. The measures focus on treatment processes and outcomes for contraception, reproductive health, pregnancy and related complications, childbirth, and neonatal health. In all, 24 measures were evaluated against NQF’s endorsement criteria and 18 received endorsement status. Nine were newly submitted measures and 15 were maintenance measures. For a complete list of measures, see the Perinatal and Reproductive Health 2015-2016 project page.

Person- and Family-Centered Care

NQF has endorsed 13 measures related to person- and family-centered care. The measures focus on quality of life, functional status, experience of care, shared decision making, symptom/symptom burden, and communication. Twelve of the 13 measures that were evaluated against NQF’s endorsement criteria were newly submitted measures and one was a maintenance measure. For a complete list of measures, see the Person and Family Centered Care 2015-2017 project page.

Any party may appeal a decision to endorse a measure reviewed in these projects by submitting an appeal no later than November 25 at 6:00pm ET.

Appeals may be submitted through the NQF measure database. For an appeal to be considered, the notification must include information clearly demonstrating that the appellant has interests directly and materially affected by the NQF-endorsed recommendations and that the NQF decision has had (or will have) an adverse effect on those interests. All appeals are published on the relevant project pages on NQF’s website.

The recently announced changes to NQF's measure endorsement procedures for decisions and appeals do not affect these projects.

Questions? Please contact project teams at cancerem@qualityforum.org, palliative@qualityforum.org, perinatal@qualityforum.org, pfcc@qualityforum.org.

Long-term oxygen treatment does not benefit some COPD patients

Thursday, October 27, 2016

Study addresses long-standing question for those with moderately low blood oxygen levels.

Newly published data from the Long-Term Oxygen Treatment Trial (LOTT) show that oxygen use is not beneficial for most people with chronic obstructive pulmonary disease (COPD) and moderately low levels of blood oxygen. It neither boosted their survival nor reduced hospital admissions for study participants. Previous research showed that long-term oxygen treatment improves survival in those with COPD and severely low levels of blood oxygen. However, a long-standing question remained whether a different group of COPD patients — those with moderately low levels of blood oxygen—also benefit. The study was funded by the National Heart, Lung, and Blood Institute (NHLBI) — a part of the National Institutes of Health—and the Centers for Medicare & Medicaid Services.

The study, the largest of its kind to evaluate the effectiveness of home oxygen in this group of patients, is published in the current online issue of the New England Journal of Medicine. The 738 patients enrolled in this study had COPD and moderately low levels of blood oxygen (in contrast to severely low blood oxygen levels) at rest or during exercise.

In the current study, patients with moderately low levels of blood oxygen are defined as those with a blood oxygen saturation (SpO2) between 89 and 93 percent at rest (moderate resting hypoxemia), or a SpO2 below 90 percent during the 6-minute walk test. Patients with severely low blood oxygen levels are defined as those with a SpO2 equal to or less than 88 percent at rest. This latter group was excluded from the LOTT study because prior studies showed that they benefit from long-term oxygen treatment. Blood oxygen saturation or SpO2 refers to the percentage of oxygen-saturated hemoglobin relative to total hemoglobin in the blood and is measured through a pulse oximeter. A pulse oximeter is a special probe that indirectly measures oxygen levels in the blood, often by attachment to the finger.

"These results provide insight into a long-standing question about oxygen use in patients with COPD and moderately low levels of blood oxygen. For the most part, this treatment did not improve or prolong life in study participants," said James P. Kiley, Ph.D., director of NHLBI's Division of Lung Diseases. "The findings also underscore the need for new treatments for COPD."

Researchers say patients with any form of COPD should check with their doctors before making changes in their treatment plans. "We want to make it clear that LOTT was not designed to assess individual responses to oxygen treatment and that individual responses can vary. Each COPD patient should discuss their own personal situation with their healthcare provider," said William C. Bailey, M.D., Professor Emeritus at the University of Alabama at Birmingham School of Medicine, and study Chair.

COPD, the third leading cause of death in the United States, is a progressive lung disease triggered primarily by cigarette smoking, although up to 20 percent of patients with COPD never smoked. Symptoms include shortness of breath, chronic coughing, and wheezing. The disease also causes low oxygen levels in the blood. About 15 million people have been diagnosed with COPD in the United States and another 10 million may be undiagnosed.

For decades, oxygen has been one of the main treatment tools for patients with COPD and low oxygen levels. It involves the use of metal tank cylinders containing oxygen or concentrators that extract oxygen from air; both systems deliver the gas through a nasal tube or mask.

The LOTT study is a randomized clinical trial to determine whether oxygen use could help COPD patients with moderately low levels of blood oxygen. The seven-year study, which included patients from 42 medical centers throughout the United States, began in 2009 and was completed in 2015.

In the study, half of the patients received long-term oxygen and the other half did not. The researchers found no significant differences between the two groups based on how long patients survived, and the amount of time leading to their first hospitalization. They also found no differences in other important benchmarks, such as the rates at which the patients were hospitalized or experienced worsening of COPD symptoms. Nor did researchers find statistically significant differences between the groups in quality of life, levels of depression or anxiety, lung function, or ability to walk for short periods.

Although no cure for COPD exists, there are a number of treatment options, including the use of bronchodilators and steroids, as well as pulmonary rehabilitation, surgery, and lung transplantation. Researchers worldwide are also studying new medications and exploring other approaches such as gene therapy. They continue to emphasize the importance of not smoking tobacco in preventing or slowing the progression of COPD.

About the National Heart, Lung, and Blood Institute (NHLBI): NHLBI, a part of the National Institutes of Health (NIH), plans, conducts, and supports research related to the causes, prevention, diagnosis, and treatment of heart, blood vessel, lung, and blood diseases; and sleep disorders. The Institute also administers national health education campaigns on women and heart disease, healthy weight for children, and other topics. NHLBI press releases and other materials are available online at www.nhlbi.nih.gov.

About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.