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Tag Archive | "PCORI"

Comparative Effectivness Methodology Committee Members Announced

On Monday, January 21, Gene Dodaro, Comptroller General of the United States with the U.S. Government Accountability Office (GAO), announced the appointment of 15 members to the Methodology Committee of the Patient-Centered Outcomes Research Institute (PCORI).  The Affordable Care Act established the PCORI as a public-private partnership to support comparative effectiveness research (CER).  The PCORI is authorized to identify research priorities and establish a research project agenda to assist patients, health care providers, and policy makers in making informed health care decisions based on clinical evidence on the most efficient and effective way to prevent, diagnose, treat and/or monitor diseases.  Additionally, the institute will adopt research priorities and submit annual reports to the President, Congress, and the public on its findings.

The Methodology Committee will develop and improve the science and methods of comparative clinical research by developing methodological standards.  In addition to the expert members appointed today, the Director of the Agency for Healthcare Research and Quality (AHRQ) and the Director of the National Institutes of Health (NIH), or their designees, are also required to serve on the committee.  The GAO announced the appointment of 19 members to the Board of Governors of PCORI in September 2010.

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Election Analysis: What It Means for Health Care Reform

After months of debate and considerable political maneuvering, President Barack Obama signed the Patient Protection and Affordable Care Act (H.R. 3590/P. L. 111-148) into law on March 23, 2010. On March 30, 2010, the President signed into law the Health Care and Education Reconciliation Act of 2010 (H.R. 4872/P. L. 111-152), which makes select changes to H.R. 3590.

Together, these laws, known as the Affordable Care Act (ACA), are designed to expand health insurance coverage to 32 million Americans who are currently uninsured, while reining in rapidly-growing health care costs.  Health care spending is the fastest growing line item in the Federal budget. Health care premiums have doubled in the last decade and have been an increasing burden to employers and employees, as well as State and local governments.

During the 112th Congress, Members will focus their attention on the implementation of the new law. The Republican gains, expanding the bloc of conservative Republicans, resulting in the control of the House and narrower margins in the Senate will bring about a focus on repealing or modifying the Affordable Care Act.

Other forces will be at play, beyond the political makeup of Congress, that may impact the trajectory of health care reform implementation. For example, in a Florida U.S. District Court, a judge allowed a lawsuit to challenge parts of the new health care reform law brought by 20 states, the National Federation of Independent Business, and two private citizens to move forward. The plaintiffs argue that the Affordable Care Act’s mandate that individuals purchase health care insurance and the Medicaid expansion violate the Commerce Clause of the Constitution. A summary judgment hearing where both the plaintiffs and defendants will have the opportunity to argue the merits of their case is scheduled for December 16. The lawsuit is likely to be heard by the Supreme Court in the next two years. A successful challenge would be a victory for Republicans and could result in major restructuring of the law.

In addition, Republicans are expected to win 6-8 governors’ races, resulting in a majority of state executive offices being held by Republicans. Control of these offices will impact funding priorities and health care reform implementation.

While there are many factors at play, the core provisions of health care reform, namely the establishment of state insurance exchanges and premium subsidies, are likely to remain intact in the law. In addition, given the enormous fiscal pressures, many of the Centers for Medicare and Medicaid Services’ (CMS) cost-cutting initiatives are likely to move forward, despite attempts to modify or repeal the reform law. Other provisions of the law, such as the creation of the Independent Payment Advisory Board (IPAB), are more likely candidates for repeal.  Regardless of the final outcome of the elections, we expect the battles regarding the health care reform law to continue up to and through the 2012 elections.

Committees of Jurisdiction

House Ways and Means Committee

Current Chairman Sandy Levin (D-MI) is expected to retain the top Democratic post on the Committee, serving as the Ranking Member of the full Committee in the 112th Congress. Ranking Member Dave Camp (R-MI) will assume the Chairmanship. Rep. Pete Stark (D-CA) will serve as Ranking Member of the Health Subcommittee. Rep. Wally Herger (R-CA) is in line to serve as the Subcommittee Chairman; however, Rep. Charles Boustany (R-LA) may contend for the position.

House Energy and Commerce Committee

Ranking Member Joe Barton (R-TX) is term limited according to GOP rules. Although he petitioned the Steering Committee to clarify whether the Republican Party’s six-year term limit is applicable to time served in the minority, it is unlikely that he will serve as Chairman. Instead, Rep. Fred Upton (R-MI), a moderate, is expected to rise to hold the top seat on the Committee. Current Chairman Henry Waxman (D-CA) will serve as the full Committee Ranking Member.  Health Subcommittee leadership will not change. Rep. Frank Pallone (D-NJ) will retain the top Democratic seat and Rep. John Shimkus (R-IL) will serve as the Chairman of the Subcommittee. Rep. Upton has signaled that he will seek to repeal the health care reform law and prioritize passage of legislation that would permanently prevent federal funds from being used for abortions. In addition to continued oversight of health care reform, the Committee will also consider Food and Drug Administration (FDA) user fee and reform legislation.

Senate Finance Committee

Sen. Max Baucus (D-MT) will retain his position as Chairman of the Committee.  However, leadership changes are expected on the Republican side of the aisle.  Sen. Orrin Hatch (R-UT) will serve as Ranking Member while current Ranking Member Chuck Grassley (R-IA) will transition to the Judiciary Committee to be the top Republican.  In addition to monitoring health care reform implementation, Senate Finance Committee Republicans will continue to call for a hearing with the Centers for Medicare and Medicaid Services (CMS) Administrator Donald Berwick, who was sworn in on July 13.  Dr. Donald Berwick is a pediatrician and professor at Harvard University and the founder the Institute for Healthcare Improvement.  He launched the“100,000 Lives” campaign to reduce the number of deaths attributable to medical errors in hospitals.  He previously served as Vice Chair of the U.S. Preventive Task Force, member of the Board of Trustees of the American Hospital Association, Chair of the National Advisory Council of AHRQ.  President Obama appointed Dr. Berwick during a recess in the middle of a session, so Dr. Berwick’s appointment will expire at the end of the first session of the 112th Congress.

Senate Health, Education, Labor and Pensions (HELP) Committee

The leadership of the HELP Committee will remain unchanged. Sen. Tom Harkin (D-IA), who has served as Chairman since the death of Sen. Ted Kennedy (D-MA) in August, will remain Chairman.  Sen. Michael Enzi (R-WY) will continue to serve as the Ranking Member of the Committee. Chairman Harkin recently established a health care investigations staff team, signaling his interest in more actively overseeing FDA policies.

House Ways and Means Committee

Current Chairman Sandy Levin (D-MI) is expected to retain the top Democratic post on the Committee, serving as the Ranking Member of the full Committee in the 112th Congress.  Ranking Member Dave Camp (R-MI) will assume the Chairmanship.  Rep. Pete Stark (D-CA) will serve as Ranking Member of the Health Subcommittee.  Rep. Wally Herger (R-CA) is in line to serve as the Subcommittee Chairman; however, Rep. Charles Boustany (R-LA) may contend for the position.

House Energy and Commerce Committee

Ranking Member Joe Barton (R-TX) is term limited according to GOP rules.  Although he petitioned the Steering Committee to clarify whether the Republican Party’s six-year term limit is applicable to time served in the minority, it is unlikely that he will serve as Chairman.  Instead, Rep. Fred Upton (R-MI), a moderate, is expected to rise to hold the top seat on the Committee.  Current Chairman Henry Waxman (D-CA) will serve as the full Committee Ranking Member.  Health Subcommittee leadership will not change.  Rep. Frank Pallone (D-NJ) will retain the top Democratic seat and Rep. John Shimkus (R-IL) will serve as the Chairman of the Subcommittee.  Rep. Upton has signaled that he will seek to repeal the health care reform law and prioritize passage of legislation that would permanently prevent federal funds from being used for abortions. In addition to continued oversight of health care reform, the Committee will also consider Food and Drug Administration (FDA) user fee and reform legislation.

Major Issues Likely to Be Addressed in 112th Congress

Health Care Reform Implementation. Prior to the election, House Republican leaders, including Minority Leader John Boehner (R-OH) and Minority Whip Eric Cantor (R-VA), announced their conservative agenda should they win enough seats in the mid-term elections to regain the majority in the House.  “A Pledge to America” proposes “to advance policies that promote greater liberty, wider opportunity, a robust defense, and national economic prosperity.” The agenda offers a plan to repeal and replace the health care reform law with “common-sense solutions focused on lowering costs and protecting American jobs.” Specifically, the Republicans plan to enact medical liability reform, allow purchase of health insurance across state lines, expand tax-free Health Savings Accounts (HSAs), ensure access for patients with pre-existing conditions, expand state high-risk pools and reinsurance programs, reduce cost of coverage, and permanently prohibit taxpayer-funded abortions.

Although the Republicans were not able to regain a majority in the Senate, the new House Republican Majority is likely to pass legislation to repeal or modify the Affordable Care Act.  Republicans have acknowledged that fully repealing the health care reform law is unlikely as long as President Obama is in office and Republicans do not have veto-proof majorities in the House and Senate. Furthermore, a Kaiser Family Foundation poll found that only 31 percent of registered voters favor full repeal of the law, making such a move politically unpopular.

While the Senate is not expected to consider legislation to fully repeal the health care reform law, House action will serve to outline the problems with the health care reform law and position the Republicans to articulate market-based solutions. The Republicans will use the next two years to relay to the American public through Congressional hearings and legislative activity that in order for changes to be enacted to the Affordable Care Act, a Republican president must be elected in 2012.

According to a Congressional Budget Office (CBO) analysis, Congress must appropriate more than $115 billion in 2010-2019 for the Internal Revenue Service (IRS) and Department of Health and Human Services (HHS) administrative costs associated with implementation as well as explicit authorizations of discretionary funding.  Republicans will certainly use the appropriations process to try to slow implementation of reform and to continue the debate about health care reform and its merits.

Health Care Reform Technical Corrections. A legislative package to correct provisions of the Affordable Care Act is expected to be introduced in the 112th Congress. Although House Republicans will not be successful in repealing health care reform in its entirety, Republicans in both the House and Senate may be able to modify provisions for which popular support could be garnered:

1099 Reporting Requirement. One provision that may be included in such a legislative package would repeal or modify the requirement that all businesses issue Form 1099 to vendors from which they purchase $600 or more of goods annually and file the information report with the IRS. The requirement is effective for payments made after December 31, 2011. The requirement was included in health care reform as a revenue raising provision that will generate $17.1 billion over 10 years. Congress considered proposals during this session to either repeal or modify the requirement. Republicans are expected to focus on this requirement as a way in which the Affordable Care Act burdens small businesses.

Independent Payment Advisory Board. The 15-member board will make recommendations to Congress to reduce excess Medicare cost growth and improve quality of care for Medicare beneficiaries. If Medicare costs are projected to be unsustainable in any given year, the Board’s recommendations will take effect unless Congress passes an alternative measure that achieves the same level of savings. Republicans have proposed eliminating the authority for the Board. Liberal House Ways and Means Committee Health Subcommittee Chairman Pete Stark (D-CA) has agreed that it is a “dangerous provision” and has pledged “to work tirelessly to mitigate the damage that will be caused by IPAB.”

Patient-Centered Outcomes Research Institute. The Affordable Care Act requires the establishment of a private, non-profit institute to identify national priorities and conduct comparative effectiveness research. Republicans have decried that such research will result in government refusal to provide coverage of more costly treatment options.

Community Living Assistance Services and Support (CLASS) Program. The law authorizes the establishment of a long-term disability insurance program for adults who have at least two functional dependencies. After a five-year vesting period, the program will provide those insured under the program with a cash benefit to purchase nonmedical services, such as home modifications, assistive technology, accessible transportation, homemaker services, respite care, personal assistance services, home care aides, and nursing support. Republican Senators have introduced legislation to repeal the program and moderate Democrats voiced opposition to the program during the health care reform debate. Senate Finance Committee Chairman Max Baucus (D-MT) has indicated that he is “no fan of the CLASS Act.”

Prevention and Public Health Fund.  The law authorizes a prevention and public health investment fund to provide an expanded and sustained national investment in prevention and public health programs. Republicans have called the fund a $2 billion-per-year slush fund that supports local government projects such as building jungle gyms. Earlier this year, Senate Republicans unsuccessfully tried to use the rollback of the prevention and public health fund to offset the cost of repealing the 1099 reporting requirement.

Medicare Physician Payment “Fix.” Earlier this year, Congress passed the “Preservation of Access to Care for Medicare Beneficiaries and Pension Relief Act of 2010,” which extended the Medicare physician fee fix through November 30, 2010. Without further Congressional action, physician payments will be cut by 23 percent beginning on December 1 and reduced by an additional 6.1 percent beginning January 1, 2011. The American Medical Association (AMA) has called for Congress to extend the fix for an additional 13 months through 2011. If Congress elects to move a short-term patch, Members will be forced to act again in the 112th Congress.

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Patient-Centered Outcomes Research Institute Board of Governors Announced

The Government Accountability Office (GAO) announced the appointment of 19 members to the Board of Governors for the new Patient-Centered Outcomes Research Institute (PCORI) established under the Affordable Care Act to expand comparative effectiveness research efforts. The appointees will join the Director of the Agency for Healthcare Research and Quality (AHRQ) and the Director of the National Institutes of Health (NIH), or their designees, as members of the non-profit organization’s Board.

Members of the Board will be appointed for a six-year term and may be reappointed for one subsequent six-year term. The terms of the PCORI board members are staggered, with the first set of appointments made in September 2010 set at two, four, and six years.

Commissioners whose first term will expire in September 2016 are:

• Eugene Washington, MD, MSc, Vice Chancellor, UCLA Health Sciences, and Dean, David Geffen School of Medicine, University of California Los Angeles. Dr. Washington will serve as the chair of the PCORI Board of Governors.

• Steven Lipstein, MHA, President and Chief Executive Officer, BJC Health Care, a non-profit health care delivery system. Mr. Lipstein will serve as the vice chair of the PCORI Board of Governors.

• Christine Goertz, DC, PhD, Vice Chancellor for Research and Health Policy, Palmer College of Chiropractic and Palmer Center for Chiropractic Research.

• Sharon Levine, MD, Associate Executive Director for The Permanente Medical Group of Northern California, a large multi-specialty group practice within Kaiser Permanente’s integrated delivery system.

• Ellen Sigal, PhD, Chairperson and founder of Friends of Cancer Research, a cancer research think tank and advocacy organization.

• Harlan Weisman, MD, Chief Science and Technology Officer, Medical Devices and Diagnostics, for Johnson & Johnson.

• Robert Zwolak, MD, PhD, a vascular surgeon at Dartmouth-Hitchcock Medical Center and professor of surgery at the Dartmouth Medical School.

Commissioners whose first term will expire in September 2014 are:

• Lawrence Becker, Director, Strategic Partnerships and Alliances, Xerox Corporation.

• Arnold Epstein, MD, the John H. Foster Professor and Chair of the Department of Health Policy and Management at Harvard University School of Public Health, and practicing internist at Brigham and Women’s Hospital.

• Andrew Imparato, JD, President and Chief Executive Officer of the American Association of People with Disabilities.

• Robert Jesse, MD, PhD, Principal Deputy Under Secretary for Health and National Program Director for Cardiology, Department of Veterans Affairs.

• Freda Lewis-Hall, MD, Chief Medical Officer and Senior Vice President of the Pfizer Medical Division.

• Grayson Norquist, MD, MSPH, Professor and Chairman, Department of Psychiatry and Human Behavior, University of Mississippi Medical Center.

Commissioners whose first term will expire in September 2012 are:

• Debra Barksdale, PhD, RN, Associate Professor, University of North Carolina (UNC) at Chapel Hill School of Nursing.

• Kerry Barnett, JD, Executive Vice President of Corporate Services and Chief Legal Officer, The Regence Group.

• Allen Douma, MD, Chief Executive Officer of Empower, LLC, and a member of the AARP Board of Directors.

• Leah Hole-Curry, JD, Program Director for the Health Technology Assessment (HTA) program, Washington State Health Care Authority.

• Harlan Krumholz, MD, Harold H. Hines, Jr. Professor of Medicine and Epidemiology and Public Health at Yale University School of Medicine.

• Richard E. Kuntz, MD, Senior Vice President and Chief Scientific, Clinical, and Regulatory Officer of Medtronic, Inc.

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