NIH Precision Medicine Initiative® (PMI) Cohort Program
The PMI Cohort Program, part of President Obama’s larger Precision Medicine Initiative, is a landmark longitudinal research effort that aims to engage 1 million or more U.S. participants to improve our ability to prevent and treat disease based on individual differences in lifestyle, environment, and genetics.
PMI Cohort Program volunteers, reflecting the rich diversity of the U.S., will contribute a wide range of health, environment, and lifestyle information. They will answer questions about their health history and status, share their genomic and other biological information through simple blood and urine tests, and grant access to their clinical data from electronic health records. In addition, mobile health devices and apps will provide lifestyle data and environmental exposures in real time. This will be accomplished with essential privacy and security safeguards. As partners in the research, participants will have ongoing input into study design and implementation. Importantly, participants will have access to a wide range of their individual data and aggregate study results.
In addition to strong participant engagement, the program will benefit from collaborations across the country with leading academic institutions, medical centers, and industry partners. The PMI Cohort Program will empower participants, healthcare professionals, and researchers to work together, creating a new model of research in which people become true partners in the process, not research subjects. Through this collaboration, the program aims to accelerate the biomedical advances that will improve the health of future generations.
Open Payments Program
The Centers for Medicare & Medicaid Services (CMS) is dedicated to providing greater transparency through education, outreach, partnership, strategic communications and data releases. Open Payments is a national program that promotes this objective by publishing data on the financial relationships between the health care industry and health care providers.
As required by the Affordable Care Act, whenever drug or medical device companies make payments to covered physicians or teaching hospitals, or when physicians or teaching hospitals have invested in these companies, this information must be reported to CMS. Reported payments include such things as consulting fees, research grants, travel reimbursements, and other gifts that drug or device companies provide to physicians and teaching hospitals. This data is then made available to the public, including patients, each year at CMS.gov/OpenPayments.
The purpose of Open Payments is to provide greater transparency to the public about the financial relationships between physicians and the health care industry. The Open Payments program does not identify financial relationships that are beneficial or those that may indicate conflicts of interest. Rather, this transparency program was intended to shed light on the nature and extent of these relationships.
CMS publishes a full calendar year (known as a “program year”) of payment data on June 30th of the following year, as well as updates from previous program periods. In addition, CMS updates or “refreshes” the Open Payments data approximately six months after its initial publication in order to reflect any data corrections made since the initial data publication.
In program year 2015, health care industry manufacturers reported $7.52 billion in payments and ownership and investment interests to physicians and teaching hospitals. This amount is comprised of 11.90 million in total records, attributable to 618,931 physicians and 1,116 teaching hospitals. Over the course of the Open Payments, program since 2014, CMS has published 28.22 million records, accounting for $16.77 billion in payments and ownership and investment interests.
CMS Blue Button
CMS established Blue Button in 2010 to allow Medicare beneficiaries to download their CMS claims history via the MyMedicare.gov portal in text or PDF formats. While these data formats are relatively easy for beneficiaries to read, they may not be sufficient to meet growing beneficiary needs around analyzing and/or sharing their health data.
As a result, CMS is working to enhance the current Blue Button service to provide a developer-friendly, standards-based data Application Programming Interface (API) that enables beneficiaries to connect their Medicare claims data to the applications, services, and research programs they trust. CMS is utilizing the HL7 Fast Health Interoperability Resource (FHIR) framework to ensure data is in a structured format that can be accepted by a wide range of applications. The agency is also putting the beneficiary in control of their own health data by designing an interface on top of the FHIR API that will enable beneficiaries to choose when to connect their data to third-party applications. The agency anticipates piloting new Blue Button functionality in the Summer/Fall of 2017.
Health Resources and Services Administration (HRSA) Maternal and Child Health Block Grant State Data System (TVIS)
TVIS is a web-based system administered that operates the three aims of the State Maternal and Child Health Block Grant Program (Title V) of reducing burden to states, maintaining state flexibility, and improving accountability. The TVIS is comprised of two parts. The first part is the Title V Maternal and Child Health Block Grant Data Entry System, which is used by state/jurisdictional Title V Block grantees to submit their annual financial, program and performance data. The second part is the TVIS Web Reports System, which is a web‑based interface that allows public users to generate reports from the Title V data. Users are able to search national and state level data on key measures and indicators of maternal and child health in the US, view national and state Title V Maternal and Child Health Block Grant financial and program data, and acquire information on an individual state Title V Maternal and Child Health Block Grant Program.
Patient-Focused Drug Development
As part of FDA’s PDUFA V commitments, the Office of Strategic Programs and the Office of New Drugs have partnered on the Patient-Focused Drug Development program. Two critical considerations in FDA’s regulatory decisions are FDA’s assessment of the disease and its severity and how well current treatment options meet the needs of patients. FDA developed a structured approach to obtain the patient perspective on these important considerations in facilitated public settings for specific diseases. With public input, FDA identified 24 disease areas to be the subject of individual meetings attended by patients and patient representatives, FDA review staff from the relevant therapeutic review divisions, regulated industry, Congressional staff, and others. The information conveyed in each meeting and in a public docket is summarized in “Voice of the Patient” reports that are made available to review staff for consideration when reviewing new proposed therapies in these disease areas. The reports are also published on FDA’s website: http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm368342.htm
Quality Rating System (QRS)
Based on Section 1311(c)(3) of the Affordable Care Act, CMS developed the Quality Rating System (QRS) to: provide useful information to consumers of Qualified Health Plans (QHPs) offered through a Health Insurance Marketplace (Marketplace), provide actionable information that QHP issuers can use for performance improvement, and facilitate oversight of QHPs. CMS also developed the Qualified Health Plan Enrollee Experience Survey (QHP Enrollee Survey) to yield consumer experience data that will be used in the QRS.
As a condition of certification and participation in the Marketplaces, QHP issuers are required to collect and submit third-party validated QRS clinical measure data and QHP Enrollee Survey response data that will be used by CMS to calculate QRS scores and ratings. The QRS measure set includes 43 measures that address areas of clinical quality management; enrollee experience; and plan efficiency, affordability, and management. QHP issuers are required to collect and submit data for 43 measures. QHP issuers should refer to each measure’s technical specifications, which specify criteria for determining the eligible population and ability to submit data for the measure.
CMS will use a standardized methodology to calculate QRS scores and ratings based on the measure data that the eligible QHP issuers submit for each of their Marketplace products by state. The methodology uses a hierarchical structure to group measures into components (composites, domains, summary indicators), which are then used to form a single global rating (using a 5-star scale) for each QHP. Throughout the development of the QRS, CMS has obtained stakeholder comment to inform every part of the program, including establishing requirements, selecting measures, developing the rating methodology and refining operations and processes for data collection, submission and validation.
CMS will pilot the display of QRS star ratings in six States whose consumers use HealthCare.gov during the 2017 open enrollment period (November 2016). The pilot will include consumer testing of the display of QRS star ratings to maximize the clarity and consistency of the information provided and to assess how the QHP quality rating information is displayed on HealthCare.gov.
Innovative and Active - A Public Comment Database Plays Role in the Physical Activity Guidelines Development Process
A unique public comment database was recently created for the Physical Activity Guidelines update process. The database, open for comment for the next two years throughout the Physical Activity Advisory Committee process, will play a role in the development of the Physical Activity Guidelines for Americans.
Office of the Assistant Secretary for Health, in collaboration with the Centers for Disease Control and Prevention, the National Institutes of Health, and the President’s Council on Fitness, Sports & Nutrition, is leading the development of the second edition of the Physical Activity Guidelines for Americans (Physical Activity Guidelines or the Guidelines). All collaborative agencies encourage and promote the use of the public comment database as an important way to provide input to the Advisory Committee members and to the Federal government.
The Physical Activity Guidelines is an essential resource for health professionals and policymakers. The current edition includes recommendations for Americans ages 6 years and over and provides science-based advice on how physical activity can help promote health and reduce the risk of chronic disease. The Guidelines serves as the primary, authoritative voice of the federal government for evidence-based guidance on physical activity, fitness, and health for Americans.
Members of the public are welcome to submit comments to the Advisory Committee for consideration as they deliberate and develop their future Scientific Advisory Report. An additional comment period will be open to submit comments to the Federal government, based on the final Physical Activity Guidelines Advisory Committee’s Scientific Advisory Report. All comments will be reviewed and used in developing the second edition of the Physical Activity Guidelines, slated for publication in 2018.