Welcome to the first edition of the government affairs Public Policy Update .
We have initiated this publication because it is important for all of us as citizens, and more particularly as members of the OSU and OSUMC community to be aware of how the actions of the local, state and federal governments can affect our day-to-day work, and our future as well. We are hopeful that keeping you informed will help us provide those in the legislative and executive branches of government with policy choices, and an understanding of how the policies they are considering could impact the work that we do.
We would appreciate your feedback as we learn how to customize this report to best fit the Medical Center needs. To that end, expect to receive a brief and easy web-based survey over the next few weeks. Future reports will be linked to our inner-web page that will be launched in the near future. Also, please take the time to respond to our request to collect information on external appointments to boards, commissions, and associations, found at the bottom of the document.
By way of introduction, the government relations team for the Medical Center consists of Jennifer Carlson
and Jerry Friedman , combined they have over 40 years of government experience.
Election Issues
Several Health Care-Related Ballot Issues For General Election:
In addition to the legislative and executive branch offices that are up for election on Tuesday, November 7, there are five statewide issues making their way through the process to appear on the November ballot.
Note: Issue 5 is supported by a coalition of health groups including the American Cancer Society, the American Heart Association, and the Ohio Hospital Association. If both Issues 4 and 5 are approved in November, Issue 4 will prevail/trump Issue 5 because the former is a constitutional amendment and the latter is an initiated statute. The National Cancer Institute (NCI) recently announced a new policy requiring all meetings and conferences sponsored or primarily funded by the NCI be held in a state, county, city, or town that has adopted a comprehensive smoke-FREE policy. If passed, Issue 4 could impact the award of NCI dollars if it were interpreted to override municipal smoking bans. Only Issues 2, 3 and 4 have currently been certified to appear on the ballot. Issues 1 and 5 continue to face legal hurdles. If the campaigns for Issues 1 and 5 do not prevail, the remaining issue numbers will not change.
OSU Issues Guidelines on Political Activities:
The OSU Office of Legal Affairs has issued political activity guidelines that were presented to the President's Cabinet on August 30, 2006. These guidelines focus on the rights and responsibilities of individual employees. Please take the time to review the attached guidelines.
State Update
The Ohio General Assembly will be back in session after the fall election. The state capital budget bill, insurance legislation to regulate discount medical plan organizations provider agreements (SB 5; ) and tax policy issues will be among the issues voted on during the lame duck session.
Standard of Care Coverage for Clinical Trials:
While clinical trials offer many cancer patients their best hope of survival by providing access to cutting-edge treatments, currently, only 3% of cancer patients enroll. Part of the problem is that many health insurers refuse coverage for a patient's routine care costs (e.g., physician visits, blood work, etc. – care the patient needs because they have cancer, not because they have enrolled in a trial) if the patient enrolls in a clinical trial. State Senator Steve Stivers (R-Columbus) has agreed to sponsor State legislation to require health plans to pay for the routine care costs when a cancer patient enrolls in a clinical trial. The legislation is very specific in its definition of routine care costs and follows the Medicare definition. It specifies that the health plan would not have to pay for the cost of the actual drug or device being tested or for the research-related costs. We are hopeful this OSUMC initiative will be introduced and considered by the General Assembly before the end of the legislative session in November .
In a parallel activity at the federal level, Congresswoman Deborah Pryce (R-Upper Arlington) has agreed to introduce a similar piece of federal legislation. Without a federal policy, cancer patients covered by self-insured Employee Retirement Income Security Act (ERISA) plans – regardless of their state's laws related to clinical trials – are not guaranteed coverage for benefits and services if they enroll in a potentially life-saving clinical trial. Many clinical trials are conducted across state boundaries; therefore, we must have a national policy that assures that patients will not be denied coverage for benefits and services simply because they have enrolled in a clinical trial.
State Public Hearing on Physician-owned Specialty Hospitals:
The conflicts of interest that face physicians who refer patients to hospitals in which they have an ownership interest continue to undercut the fair competition that exists among full-service hospitals in the community. Although there was much discussion at the state and federal levels, the temporary moratorium on the building of these facilities were not renewed.
At the federal level, CMS leveraged a recalibration of the Medicare Prospective Payment System on the argument that certain procedures that were high on physician self-referral lists were overly generous. The shift will push higher reimbursement to medical services, rather than procedures. While this helps Medicare's current budget problems, it does little to correct the incentives for self-referral.
At the state level, the Taft Administration recently held three public hearings (link to recent testimony) to field comments on the impact that the expiration of the federal moratorium on specialty hospitals will have on the state's hospital system. The hearings are designed to gather input from health care providers and other stakeholders and to fully understand how the end of the federal moratorium will impact our community-based hospitals and the individuals they each serve. We are working with legislative leaders on a potential change to the state definition of hospital to include access to nursing services, physicians and an emergency department 24 hours and day, seven days a week, along with providing basic laboratory, radiology, and dietary services, along with objective quality assurance and infection control services, transfer agreements and the requirement to participate in Medicare.
Pending State Rules:
· Not for Profit hospitals - State Attorney General Jim Petro filed rules with the Joint Committee on Agency Rule Review (JCARR) that would require hospitals and other charitable health care organizations to register and annually file their IRS Form 990 with the attorney general's (AG) office. Many changes were made from the existing proposed rule, including requiring all nonprofit entities to file their IRS forms annually with the AG's office. The rule establishes a charitable advisory council to advise the AG on various issues, including governance, administration and model policies. Hospitals will have a designated seat on the council (http://www.ag.state.oh.us/press/06/09/pr060906.asp).
Board of Regents & Higher Education :
House Bill 66, the state biennial budget, set forth a number of budget related activities for higher education. The Higher Education Funding Study Commission was created to review the various higher education funding formulae and make recommendations regarding the role of higher education in supporting the evolution of a 21 st century economy for the state. In addition the Board of Regents was required to consult with the state assisted medical schools regarding recommendations for a formula distribution of clinical teaching subsidies. And finally, Regents were asked to consult with a variety of stakeholders regarding physician supply and demand for the state of Ohio.
The higher education study concluded that the state needed significant additional investments in higher education; and at least part of that increase should be targeted to areas of science, technology, engineering, mathematics and medicine (STEM 2) . In addition, they recognized an impending shortage of medical services in Ohio and asked that an assessment be conducted, and appropriate funding be made available to meet projected needs, and to provide appropriate levels of support.
The policy recommendations will translate to requests for appropriations in the next biennial budget to be introduced by the new governor in 2007.
Federal Update
With only two (Defense and Homeland Security) of the twelve annual spending bills enacted before the start of federal fiscal year 2007 on October 1, lawmakers will have to decide after the November elections whether to extend stopgap funding, try to enact bills separately, or wrap them into an omnibus appropriations bill.
More on Federal Appropriations :
The stopgap continuing resolution enacted as part of the Defense spending bill earlier last week will keep the federal government running through November 17. The pursuit of an omnibus strategy and long-term continuing resolution to keep agencies operating puts at risk specific Congressionally designated projects for the Medical Center, including funding for our new cancer hospital and berries research project. Congress has ended up with an omnibus to complete its annual appropriations business every election year since 1996.
The Labor-HHS-Education bill (HR 5647) in particular has many thorny elements that will make enactment difficult – the bill contains a minimum wage increase. The bill represents the largest allocation of domestic discretionary spending. Earlier this year, House leaders indicated that they would boost funding for the Labor-HHS-Education bill by $3 billion, bringing it $7 billion above the administration's request for National Institutes of Health (NIH) and education. Both the House and Senate reduced their Defense spending levels to provide additional money for the bill.
The Senate Appropriations Committee approved $142.8 billion in discretionary funding for FY 2007, an increase of $1.27 billion (0.9 percent) over FY 2006. The bill includes $28.459 billion for the National Institutes of Health, an increase of $220 million (0.8 percent) over FY 2006 and $200 million over the Administration's budget recommendation. It also provides $9 million more for the National Cancer Institute. The Senate version is $201 million over the $28.26 billion approved by the House Appropriations Committee. Differences between the two chambers will be resolved this fall after the elections.
NIH Announces Policy for Funding Non-Competing Awards:
Until its final FY07 appropriation is approved, NIH (link: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-004.html ) will fund non-competing grant awards at a level “below that indicated on the most recent Notice of Award (generally up to 80% of the previously committed level). NIH “will consider upward adjustments to these levels after the final appropriation is enacted, but expects institutions to monitor their expenditures carefully during this period.” NIH adopted this same policy last year when the FY06 appropriation was delayed.
NIH Reauthorization Clears the House and Waits Senate Action:
This week, the House passed the National Institutes of Health Reform Act of 2006, (H.R. 6164) by a vote of 414-2 under a suspension of the rules. The Chairman of the House Energy and Commerce Committee, Representative Joe Barton (R-TX), has indicated that a National Institutes of Health (NIH) reauthorization bill is a major 2006 priority and will work with the Senate in an attempt to pass the measure this year. Although it is not necessary for continued operation, the NIH has not been reauthorized since 1993 and has been under intense scrutiny by Congress. Congressman Paul Gillmor (R-OH) offered committee report language on behalf of our Comprehensive Cancer Center to urge the NCI to increase funding for our Cancer Center Support Grant by 42%. The bill awaits Senate debate. The legislation calls for the NIH budget to increase by 5% annually for fiscal years 2007 through 2009. The bill also would establish a "common fund" to subsidize research that involves multiple NIH institutes or centers. In addition, the legislation would establish a review board to examine the structure of NIH and would require the agency to implement an electronic system to track research grants and other actions.
President Vetoes Stem Cell Bill and Sponsor Proposes Non Legislative Policy Changes:
The House passed H.R. 810, The Stem Cell Research Enhancement Act, in May, 2005, on a 238-194 vote. The bill would allow federal funding for research on stem cells taken from surplus embryos at in vitro fertilization clinics that would otherwise be destroyed. The Medical Center went on record for supporting the legislation and encouraged our Congressional delegations' support. On July 18, 2006, the Senate passed H.R. 810 by a vote of 63 to 37, four votes short of the two-thirds needed to override a veto. The next day, President Bush vetoed the bill, the first of his administration, followed by a failed attempt by the US House to override the veto.
Representative Michael Castle (R-Del.), sponsor of H.R. 810, recently unveiled a new strategy to advance embryonic stem cell research that bypasses legislative action and enlists philanthropic organization. These proposed policy changes include:
The President signed (S. 3504), the " Fetus Farming Prohibition Act of 2006 ," which bans the practice of "fetus farming," or creating embryos just for research purposes. A third bill (S. 2754), the " Alternative Pluripotent Stem Cell Therapies Enhancement Act ," which directs the National Institutes of Health to focus on federal funding for stem cell research not involving embryonic cells passed the Senate, but failed to get the two-thirds vote needed to suspend House rules and consider it.
CMS Clinical Research Trials Policy May Be Revised:
The Centers for Medicare and Medicaid Services (CMS), on July 10, 2006, issued a Tracking Sheet (CAG-00071R) to reconsider the National Coverage Decision (NCD) on coverage of clinical trials issued by CMS in September, 2000. The NCD provides Medicare payment for routine patient costs in certain clinical trials. Now called the " Clinical Research Policy ," it will address ten areas concerning the NCD.
CMS states there are three overarching goals of the proposed revised Clinical Research Policy when issued: "1) to allow Medicare beneficiaries to participate in research studies; 2) to encourage the conduct of research studies that add to the knowledge base about the efficient, appropriate, effective, and cost-effective use of products and technologies in the Medicare population, thus improving the quality of care that Medicare beneficiaries receive; and 3) to allow Medicare beneficiaries to receive care that may have a health benefit, but for which evidence for the effectiveness of the treatment or service is insufficient to allow for full, unrestricted coverage." Several interested parties submitted comments to CMS (see above link for further details).
Recently the House passed the "Health Information Technology Promotion Act of 2006" ( H.R. 4157 ). The bill amends the self-referral ("Stark") and anti-kickback laws to provide exceptions/safe harbors for health information technology (HIT) and training services. The exceptions/safe harbors apply to hospitals, group practices, prescription drug plan sponsors, Medicare advantage organizations, or any other such entity specified by the Secretary. The bill also does the following:
· Within three years, the Secretary must complete a study determining the impact of such changes on rate of HIT adoption, types of resources offered to providers, changes in provider relationships, and healthcare quality;
· Provides similar exceptions/safe harbors for consortia of healthcare providers, payers, employers and others to either collectively purchase and donate health information technology or offer a choice of technologies that take into account the varying needs of such providers;
· Directs the President to promote the advancement of healthcare quality and health research by allowing access to "useful categories" of non-identifiable electronic health information;
· Provides $15 million in matching grants in both FY 2007 and FY 2008 to help integrated health systems use HIT to better coordinate the provision of care;
· Directs the HHS Secretary to implement ICD-10 codes by October 1 st , 2010. However, the Secretary can not demand a "level of specificity" that requires documentation of "non-medical information;" and
· Directs the HHS Secretary to study whether there is a need for "greater commonality" in state privacy laws and regulations.
The bill, which contains several other related provisions, must now be reconciled with the Senate's bill ( S. 1418 ). The Senate bill does not include the Stark and anti-kickback provisions. It also provides a higher level of funds for purchasing HIT.
Other Legislation of 109 th Congress:
The House Energy and Commerce Committee approved HR 5472 that would reauthorize the National Breast and Cervical Cancer Program (PL 101-354; 1990), by providing cancer screening to uninsured and underserved women through fiscal year 2011. The Centers for Disease Control and Prevention (CDC) administers the program, which has provided more than 5.8 million screening exams to more than 2.5 million underserved women. The legislation would authorize the Health and Human Services (HHS) secretary to waive, for two-year periods, requirements for awarding breast and cervical cancer grants to states if certain conditions are met. The waiver conditions would include granting the waiver if it will not reduce the number of women in the state receiving examinations and screening for breast or cervical cancer; the quality of services; or the state will not use the waiver to leverage private funds to supplement the services. The waivers would enable HHS to direct more resources to outreach efforts that target hard-to-reach populations. A Senate companion measure (S.1687) awaits consideration by the Health, Education, Labor and Pensions Committee.
House Ways and Means Committee two weeks ago approved HR 5262, Tax Free Health Savings Act , designed to expand health savings accounts (HSAs) by a 24-14 vote. The Senate related measures ( S.2549 ; S.2554 ) have seen no action. Created as part of the 2003 Medicare drug law, health savings accounts allow those with high-deductible insurance plans to set up a tax-free savings account to cover health care expenses. The bill aims to increase the use of HSAs by raising contribution limits and allowing transfers from other accounts.
The House Judiciary Committee recently approved HR. 4997 , providing a two-year extension of the J-1 visa waiver program, rather than making it permanent, as the original version proposed. The J-1 visa waiver program allows foreign doctors to remain in the United States for three additional years after they complete their residencies, provided they agree to practice in medically underserved areas. Foreign students who come to the United States for graduate or post-graduate medical education are typically required to leave the country for two years before applying to return. But the 1994 law allows a waiver of that requirement in cases where the holder of a J-1 visa agrees to spend three years working with patients in medically underserved areas.
The House Energy and Commerce Committee recently approved H.R. 5533 . The Biodefense and Pandemic Vaccine and Drug Development Act. The legislation establishes a Biomedical Advanced Research and Development Authority (BARDA) within the Department of Health and Human Services to oversee development of products that defend against bioterrorism and major naturally occurring illnesses such as pandemic flu.
Calling All Appointees
We are in the process of compiling a list of external appointments to boards, commissions, and associations. Once completed, we plan to assess the list and proactively seek out opportunities for the Medical Center. Please let us know your specific external appointment by Friday, November 3 by responding to jennifer.carlson@osumc.edu.
Government Relations Team
Jennifer K. Carlson
Director of Government Relations
The Ohio State University Comprehensive Cancer Center
- Arthur G. James Cancer Hospital and Richard J. Solove Research Institute
300 West 10th Avenue , Room 522
Columbus , Ohio 43210
ph: (614)293-0346 fx: (614)293-7130
cell: (614)205-3418
e-mail: jennifer.carlson@osumc.edu
Jerry Friedman
Advisor for Health Policy & Director of Government Relations
The Ohio State University Medical Center
370 W. 9th Ave. / 200G Meiling Hall
Columbus , OH 43210-1238
Jerry.Friedman@osumc.edu
ph: 614.292.7130
614.292.3856 direct
fx: 614.688.8644