Recently the US Preventative Services Taskforce (USPSTF or Taskforce) released controversial recommendations on breast and prostate cancer screening which have patient groups exploding with anger. The prostate cancer screening recommendations call for the end of PSA tests and were released in May. This was followed by a Centers for Medicare and Medicaid Services (CMS) Medicare blog post encouraging all men over the age of 50 to get their PSA checked. These types of mixed signals are common for government but the timing was poetic at best and helps to emphasize the need for greater transparency regarding taskforce decisions.
To address these controversies, Congresswoman Blackburn (R-TN) and Congressman Barrow (D-GA) of Congress recently introduced the USPSTF Transparency and Accountability Act of 2012. The legislation makes several changes to the makeup and operations of the taskforce.
Background on Taskforce
Created in 1984, the USPSFT is an independent group of national experts in prevention and evidence-based medicine that works to improve the health of all Americans by making evidence-based recommendations about clinical preventive services such as screenings, counseling services, or preventive medications. The USPSTF is made up of 16 volunteer members who come from the fields of preventive medicine and primary care, including internal medicine, family medicine, pediatrics, behavioral health, obstetrics/gynecology, and nursing. All members volunteer their time to serve on the USPSTF, and most are practicing clinicians.
When Congress authorized the USPSTF, it required the Department of Health and Human Services (HHS) to support the Task Force’s work. The 1998 Public Health Service Act and the 2010 Patient Protection and Affordable Care Act instruct AHRQ to provide administrative, research, technical, and communication support to the Task Force. As part of this support, AHRQ helps with day-to-day operations, coordinates the production of evidence reports, ensures consistent use of Task Force methods, and helps disseminate Task Force materials and recommendations. The Director of AHRQ also appoints new USPSTF members, with guidance from the Chair of the Task Force. While AHRQ staff supports the Task Force, it is important to note that the Task Force is an independent body, and its work does not require AHRQ or HHS approval.
Proposed Legislation
First, the proposed legislation would change the composition of the Task Force. Under the legislation, the Task Force must be composed of individuals that collectively have appropriate scientific expertise, including in fields of health sciences research, health economics, and clinical care. The Task Force must include balanced representation of (1) practicing primary and specialty care providers; (2) patient and health care consumers, and (3) relevant stakeholders from the medical products manufacturing community.
Second, the legislation requires the Director of the USPSTF to disclose conflicts of interest (including personal as well as financial conflicts of interest) of any member of the Task Force that have the potential to bias (or may be perceived as biasing) individual decisions of the Task Force.
The Task Force must publish one or more proposed research plans to guide the Task Force’s systematic review of the evidence. Each such plan must include (1) an analytic framework, (2) key questions, and (3) a literature search strategy or research approach, and must incorporate specified methodological guidelines. HHS will provide for the publication in the Federal Register of a request for public comments on each plan and will accept comments during a period of at least 60 days. Any final research plan must be made available to the public and include a discussion of the comments received and responses to such comments. The Task Force may change such a research plan through the same process as applied to the initial adoption of such plan.
The Director must design and regularly update guidelines for proper methodological standards for incorporation into such research plans. Such guidelines must include measures for (1) appropriate validity; (2) for risk adjustment; (3) for timeliness; (4) for input from relevant experts and peers in the respective communities; (5) for accounting for all relevant subpopulations (including disparities by race, ethnicity, and socioeconomic status); and (6) for other health outcome measurements.
The Director must facilitate coordination and interaction with other agencies and departments in the creation of research plans (taking into consideration research and findings by other agencies and departments) and methodological standards, including with the National Institutes of Health (NIH), the National Cancer Institute (NCI), the National Institute on Minority Health and Health Disparities, the Centers for Disease Control and Prevention (CDC), the Department of Defense (DOD), the Department of Veterans Affairs (VA), the Centers for Medicare & Medicaid Services (CMS), and the Patient-Centered Outcomes Research Institute (PCORI).
Before voting on a draft recommendation statement, the Task Force must consult with relevant stakeholders, including provider groups, practicing specialists that treat the specific disease under review, and relevant patient and disease advocacy organizations.
The Director must make publicly available each draft evidence report and publish in the Federal Register a request for public comments on such reports. No such evidence report will be published prior to it being reviewed by a panel of external subject matter experts that includes provider and patient representatives. Each such report must include a description of the panel that conducted such review. Such description must include information on each panel member, including name, academic degree (or degrees), affiliations, and related expertise.
The Director must make publicly available each draft recommendation and must provide for the publication in the Federal Register of a request for comments and accept comments during a period of not less than 60 days. The Director must make such comments received publicly available. Any final recommendation statement must include a description of comments received on the draft recommendation statement and recommendations of other Federal agencies or organizations relating to the topic of the statement.
In publishing recommendation statements, the Task Force must consider the impact of its recommendations on the health care community, (1) whether a preventive service is beneficial for some individuals and the need to encourage a discussion of benefits and risks for those individuals, and (2) how its specific assignment of a grade to a product or service may affect coverage and access to such product or service under Federal programs and private health insurance coverage. In publishing recommendation statements, the Task Force will grade products and services consistent with the following:
GRADE A: The Task Force concludes that the current evidence is sufficient to assess the balance of benefits and risks of the product or service, and, on the basis of such evidence, recommends the product or service and determines that there is high certainty that the net benefit from the product or service is substantial.
GRADE B: The Task Force concludes that the current evidence is sufficient to assess the balance of benefits and risks of the product or service, and, on the basis of such evidence, recommends the product or service and determines that there is high certainty that the net benefit of the product or service is moderate or there is moderate certainty that the net benefit of the product or service is moderate to substantial.
GRADE C: The Task Force concludes that the current evidence is sufficient to assess the balance of benefits and risks of the product or service, and, on the basis of such evidence, does not make a recommendation of the product or service and clinicians may provide this product or service to selected patients depending on individual circumstances. However, for most individuals without signs or symptoms there is likely to be only a small benefit from this product or service.
GRADE D: The Task Force concludes that the current evidence is sufficient to assess the balance of benefits and risks of the product or service, and, on the basis of such evidence, recommends against the product or service and determines that there is moderate or high certainty that the product or service has no net benefit or that the harm of the product or service outweighs the benefits. Recommendations against a preventive service shall only be issued in concurrence with the Secretary after consultation with other Federal health agencies and relevant patient and provider groups.
GRADE I: The Task Force concludes that the current evidence is not sufficient to assess the balance of benefits and risks of the product or service.’’
The Task Force must convene a preventive services stakeholders board (in this subsection referred to as the ‘board’) composed of representatives of appropriate public and private entities with an interest in clinical preventive services to advise the Task Force on developing, updating, publishing, and disseminating evidence-based recommendations on the use of clinical preventive services. The members of the board must include representatives of the following: (i) Patient groups; (ii) Providers of clinical preventive services, including community-based providers and specialty physicians; (iii) Federal departments and agencies; and (iv) Private health care payors.
The board must (i) recommend clinical preventive services for review by the Task Force; (ii) suggest scientific evidence for consideration by the Task Force related to reviews undertaken by the Task Force; (iii) provide feedback regarding draft recommendations by the Task Force; and (iv) assist with efforts regarding dissemination of recommendations by the Director of the Agency for Healthcare Research and Quality.
Members of the Task Force or the board will be considered to be special Government employees within the meaning of section 107 of the Ethics in Government Act of 1978 (5 U.S.C. App.) and section 208 of title 18, United States Code, for the purposes of disclosure and management of conflicts of interest under those sections. Members of the Task Force or the board will not receive any pay for service on the Task Force or board, but may receive travel expenses, including a per diem.
