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    • Nevada AB 259
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The PIPC Blog

PIPC Weekly Update: August 13, 2018

8/13/2018

 
Picture
In This Week’s Issue:
 
1. Joint Letter with 50 Signatures to CMMI Emphasizing Early Patient Engagement in New Payment Models, click here to read the letter. 
2. CVS Launches Program To Exclude New Drugs Deemed Not Cost Effective, click here to read the article.
3. CSC Submits Comment Letter to ICER Regarding Prostate Cancer Treatment, see details below.
4. Other Upcoming ICER Studies: Spinal Muscular Atrophy, Cardiovascular Disease, Asthma, Opioid, Hereditary Angioedema, Amyloidosis, click here to provide input.
5. Supporting Wellness: A Survey of Lived Experience and Research Priorities for Depression and Bipolar, click here to take the survey.
6. CMS Guidance: Medicare Advantage Prior Authorization and Step Therapy for Part B Drugs, see details below.
7. CARE About Fibroids Call for Patient Stories: Uterine Fibroids, click here to submit your story.
8. National Meeting on Active Duty and Veteran Women’s Health, see details below.
9. 2018 PCORI Annual Meeting, click here for details.
10. PCORI Peer Review Opportunity, click here to apply.
11. Upcoming Events and Webinars, see details below.
12. Medical Journal Articles, see details below.
13. AHRQ Effective Program Updates, see details below. 

1. Joint Letter with 50 Signatures to CMMI Emphasizing Early Patient Engagement in New Payment Models
 
Almost 50 leading organizations representing patients and people with disabilities submitted a joint letter with PIPC to the Centers for Medicare and Medicaid Innovation (CMMI), urging the agency to act on their statute’s call for alternative payment models to be evaluated based on patient-centeredness criteria. PIPC Chairman Tony Coelho emphasized that when it comes to payment model development, CMMI must engage patients early in their work to develop and implement new models. Specifically, the letter offers three concrete steps to establish the criteria called for by CMMI’s statute: (1) Establish the “patient-centeredness criteria” mandated under Section 1115A of the Affordable Care Act, which requires evaluation of alternative payment models (APMs) against patient-centeredness criteria; (2) convene patient and consumer advisory panels for each of the Innovation Center models under development as well as those currently being implemented; and (3) define “informed decision-making” as a core criterion of patient-centeredness and a goal of each alternative payment model. Click here to read the letter. 
 
2. CVS Launches Program To Exclude New Drugs Deemed Not Worth the Cost-Per-QALY 
 
CVS Caremark announced a program that would allow for the exclusion of drugs from their formularies based on the flawed quality-adjusted-life-year metric, a metric routinely criticized for discriminating against people with disabilities and patients with serious chronic conditions when used to determine coverage and access to care. The new plan would allow for the exclusion of any treatment costing over $100,000 per QALY from health plans based on reports from the Institute for Clinical Economic Review (ICER). Click here to read the article. (subscription required). 
 
3. CSC and Others Submit Comment Letters to ICER Regarding Prostate Cancer Treatment
 
On August 9, 2018, patient organizations provided comments to the Institute for Clinical Economic Review (ICER) on its study of Antiandrogen Therapies for Nonmetastatic Castration-Resistant Prostate Cancer.  Cancer Support Community (CSC) reiterated its ongoing concerns that ICER’s value framework to determine cost effectiveness relies on a "budget impact” and advocated for increased use of patient-centered data sources and the inclusion of patient-defined outcomes in its assessment.  CSC was able to provide specific insights from its Prostate Cancer Spcialty Registry Report. Click here to view the CSC comment letter.  Additionally, these points were largely reiterated in a letter submitted to ICER by other PIPC members such as CancerCare and Men’s Health Network, which should be available on the ICER website in the near future. 
 
4. Other Upcoming ICER Studies: Spinal Muscular Atrophy, Cardiovascular Disease, Asthma, Opioid, Hereditary Angioedema, Amyloidosis
 
The Institute for Clinical Economic Review (ICER) conducts cost effectiveness studies for insurers using the cost-per-QALY methodology. ICER provides guidance on its website for patients and patient advocates to provide direct input related to their experiences with the disease. Click here to provide patient input. Please note the following upcoming formal ICER deadlines per their website:
 
Prostate Cancer: Evidence Report Due 8/24/2018
Amyloidosis: Comment Period Now! 7/20/18-8/17/18
Hereditary Angioedema: Draft Voting Questions Due 8/21/2018 
Opioid Use Disorder: Draft Evidence Report 9/5/2018
Asthma: Draft Voting Questions 9/24/2018
Atherosclerotic Cardiovascular Disease: Comment Period Now! 8/1/18-8/22/18
Spinal Muscular Atrophy: Comment Period Soon! 8/22/18-9/7/18
 
5. Supporting Wellness: A Survey of Lived Experience and Research Priorities for Depression and Bipolar
 
The Depression and Bipolar Support Alliance and the Milken Institute Center for Strategic Philanthropy have partnered for a new initiative that seeks to understand how adults affected by depression and bipolar describe wellness and what types of research matter most to them. “If you or a loved one have been affected by depression or bipolar disorder, we want to hear YOUR voice. Your experiences are needed to discover, develop, and deliver better medical products and care services. The Milken Institute and DBSA hope to bring thousands of voices from the community to the forefront of mental health treatment and research conversations. Take and share this survey so that we can include the diversity of voices in the discussion of mental health research.” Click here to take the survey.
 
6. CMS Guidance: Medicare Advantage Prior Authorization and Step Therapy for Part B Drugs
 
On August 7, 2018, CMS announced it will provide Medicare Advantage plans the option of applying step therapy for physician-administered and other Part B drugs. MA plans will have the choice of implementing step therapy, a type of prior authorization, to manage Part B drugs, beginning January 1, 2019 as part of "broader care coordination activities that include patient rewards and incentives.” Click here to view the CMS announcement.  In response, Reps. Phil Roe (R-TN) and Ami Bera (D-CA) are asking colleagues to join them on a letter asking CMS Administrator Seema Verma to inform Medicare Advantage plans they can't use prior authorization to inhibit access to services.  Click here to view the media report.  The American College of Rheumatology (ACR) expressed its "extreme disappointment” stating the "policy puts insurance companies in control of patient treatment plans.”  Click here to view the ACR statement.  The American Cancer Society - Cancer Action Network stated, “Going through cancer treatment is hard enough – cancer patients should not be forced to 'fail first' on a drug that is known not to work for them before they are allowed to take the recommended treatment.” Click here to view the ACS-CAN statement. 
 
7. CARE About Fibroids Call for Patient Stories: Uterine Fibroids
 
PIPC Member CARE About Fibroids is seeking stories from patients who suffer from uterine fibroids as a part of their ongoing efforts to boost education and awareness.” As part of our efforts for Uterine Fibroids Awareness Month, CARE About Fibroids is launching an initiative to collect first-hand stories from patients who have experienced symptomatic uterine fibroids. The information we are collecting from you can be relayed to us anonymously and will not be shared -- however, we may be interested in including your story as part of a research paper on uterine fibroids that we are developing (you can indicate below if you are willing to be part of our research paper). We know your stories will help inform our work to raise awareness about uterine fibroids and learn how we can educate patients in even greater ways than currently available.” Click here to submit your story. 
 
8. National Meeting on Active Duty and Veteran Women’s Health
 
Do you have patients that are active duty and veteran women? Register to attend the National Meeting on Active Duty and Veteran Women’s Health in Washington, DC on August 27 to discuss best practices in and new research on delivering quality care to military women, particularly in traditional clinical settings. The meeting is free to attend and will be live streamed here for those unable to attend in person. 
  
9. 2018 PCORI Annual Meeting
 
The 2018 PCORI Annual Meeting will take place on Wednesday, October 31, 2018 to Friday, November 2, 2018 in Washington, DC. “As part of this year's theme, ‘From Evidence to Impact: Putting What Works into Action,’ attendees will hear about results from PCORI’s comparative clinical effectiveness (CER) studies, efforts to promote essential findings, and those findings’ impacts. We will also discuss important trends in patient-centered outcomes research and connect with colleagues to share ideas for future research opportunities that will help patients and those who care for them make better-informed healthcare decisions. We are pleased to host two keynote speakers, Amy Berman, RN, Senior Program Officer, John A. Hartford Foundation, and Mark Smith, MD, founding president, California Health Care Foundation.” Click here for details.
 
10. PCORI Peer Review Opportunity
 
PCORI is seeking patients and stakeholders to review for upcoming PCORI-funded research studies that have reached completion. Of particular need are reviewers who have had, or have considered, bariatric surgery, as well as those who identify as African American and/or Latino who are living with asthma or serve as a caretaker for an older adult with asthma are of a particular need. The goal of peer review is to ensure that the primary research studies funded by the Patient Centered Outcomes Research Institute (PCORI) are held to the highest standards of scientific integrity, methodological rigor, and usefulness to patients, caregivers, clinicians, and other healthcare stakeholders.  If you’re interested or know someone who is interested in participating in this capacity, please contact Kira Lesley with Editorial Office for PCORI Peer Review at [email protected]. Click here for additional details. Click here to apply for a scholarship to attend.
 
11. Upcoming Events and Webinars 
              
PCORI Type 2 Diabetes Mellitus Expert Meeting
August 27, 2018
Click here for details.
 
PCORI Online: Cycle 2 2018 Application Submission Webinar
August 28, 2018
Click here for details.
 
Cycle 3 2018 Improving Methods Applicant Town Hall
October 17, 2018
Click here for details.
 
eyeforpharma Value Summit 2018
November 7-8, 2018
Click here for details.
 
Advisory Panel on Clinical Effectiveness and Decision Science Fall 2018 Meeting
November 30, 2018
Click here for details.
 
2019 NEC Symposium
June 2 - 5, 2019,
Click here for details.
 
12. Medical Journal Articles
 
Building Meaningful Patient Engagement in Research: Case Study From ADVANCE Clinical Data Research Network, click here to view. 
 
A Novel Stakeholder Engagement Approach for Patient-Centered Outcomes Research, click here to view. 
 
Multistakeholder Engagement in PCORnet, the National Patient-Centered Clinical Research Network, click here to view. 
 
Return of Research Results to Study Participants: Uncharted and Untested, click here to view.
 
Inverting the Patient Involvement Paradigm: Defining Patient Led Research, click here to view. 
 
Stakeholder-Driven, Consensus Development Methods to Design an Ethical Framework and Guidelines for Engaged Research, clickhere to view. 
 
The Effect of Medical Technology Innovations on Patient Outcomes, 1990-2015: Results of a Physician Survey, click here to view. 
 
The Impact of Individual Patient Data in a Network MetaAnalysis: An Investigation into Parameter Estimation and Model Selection, click here to view. 
 
Patient Similarity for Precision Medicine: A Systematic Review, click here to view. 
 
Multi-Stakeholder Engagement in Health Services Research, click here to view. 
 
Care Transitions From Patient and Caregiver Perspectives, click here to view. 
 
Incorporating Quantitative Patient Preference Data into Healthcare Decision Making Processes: Is HTA Falling Behind? Click here to view. 
   
13. AHRQ Effective Program Updates
 
Nonsurgical Treatments for Urinary Incontinence in Women: A Systematic Review Update, click here to view. 
 
Randomized Trial of a Patient-Centered Decision Aid for Promoting Informed Decisions about Lung Cancer Screening: Implementation of a PCORI Study Protocol and Lessons Learned, click here to view. 
 
Collaboration Is Key to Accelerating Diagnostics Access to Optimize Benefits of Precision Medicines, click here to view. 
 
Registries for Evaluating Patient Outcomes: A User’s Guide Call for Case Examples, click here to view. 
 
Telehealth for Acute and Chronic Care Consultations, click here to view. 
 
Library of Patient-Centered Outcomes Research Resources, click here to view. 
 
Mobile Health Applications for Self-Management of Diabetes, click here to view. 
 
Role of Immunotherapy in the Treatment of Asthma, click here to view. 
 
Library of Common Data Definitions: Atrial Fibrillation, click here to view.
 
Library of Common Data Definitions: Asthma, click here to view. 
 
Patient or Participant Generated Registries, click here to view. 
 
Effects of Dietary Sodium and Potassium Intake on Chronic Disease Outcomes and Related Risk Factors, click here to view. 
 
Prioritization and Selection of Harms for Inclusion in Systematic Reviews, click here to view. 

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