Congress
Senate Passes Health Reform
Congressional Conference Committee Is Next Hurdle
Now that the United States Senate has passed a health care reform measure, the next step in the process will be to put together a bill through a joint House and Senate Conference Committee. The trick for Congressional Democrats will be to pull together a bill that can pass both the House of Representatives and the Senate to proceed to final passage and ultimately to the President’s desk for his signature. The House and Senate Conference Committee will be very powerful and is expected to work out differences between the House and Senate bills in order to meet the President’s deadline of his State of the Union address.
In the final days of Senate debate, a few changes were made to the Senate’s health care reform bill via a manager’s amendment. The changes included the elimination of the proposed annual enrollment fee for physicians participating in Medicare and Medicaid.
A great deal of power rests with the members of the conference committee because they will have the final say on what Congress’s health care reform legislation will include before it comes back to each chamber for final passage.
Fate of Specific Provisions of Interest Still Unclear
Still unresolved is whether the final bill will include a permanent or semipermanent fix to the Medicare sustainable growth rate (SGR) formula. If the House/Senate Conference Committee does not include a SGR fix in the final version, Congress will have to revisit the issue sometime over the next 60 days because the 21 percent cut to physicians originally scheduled for January 1 will go into effect March 1.
The Senate version of the legislation also includes the appointment of an Independent Medicare Commission and the establishment of a Center for Medicare and Medicaid Innovation. Both of these entities would yield a great amount of power and have the potential to shape medicine and ultimately affect pathology’s future.
Laboratory-Related Provisions Will Be Reconciled
In September ASCP and the pathology community successfully removed a Senate Finance Committee provision that would have implemented a 20 percent co-pay on Medicare-covered laboratory tests and a tax on all clinical laboratory and pathology revenue. More than 2,500 letters were sent through the ASCP e-Advocacy Center in a 48-hour period to defeat the proposed co-pay.
However, the legislation that passed the House and the Senate included proposals to reduce the annual adjustment to the clinical laboratory fee schedule (CLFS) by an amount equivalent to the estimated annual increase in productivity, as determined by the U.S. Dept. of Labor. Historically, such estimates have averaged about 1.4 percent.
In addition, the Senate version imposes a 1.75 percent reduction in the CLFS, also effective in 2011. The Senate bill also extends the provision allowing for technical component billing by independent laboratories performing services for Medicare inpatients and “reasonable reimbursement” for laboratory services provided at small rural hospitals. There is also a provision calling on the Centers for Medicare and Medicaid Services to submit a report to Congress outlining recommendations for legislative and administrative actions to reform the reimbursement mechanisms for new clinical laboratory tests.
Legal Proceedings
Gene Patent Case Moving Forward
Despite an attempt by the defendants to have the case dismissed, the lawsuit challenging the legality of gene patents filed this summer by the American Civil Liberties Union, the ASCP, and a number of other scientific organizations, researchers, patient advocate groups, and patients will move forward.
The three named defendants, Myriad Genetics, the Directors of the University of Utah Research Foundation, and the U.S. Patent and Trademark Office (USPTO) moved to dismiss on technical grounds. The USPTO claimed it was improper to add them as defendants relying on cases holding that the USPTO should not be a party to a case challenging the validity of a patent. They contend that the suit should be solely between the patent holder (Myriad) and the plaintiffs. Both Myriad and the University argued that none of the plaintiffs lacked “standing,” a legal doctrine that insures that the plaintiffs are affected by the existence of the patents. They claimed that none of the plaintiffs were prepared to sequence and/or analyze BRCA genes or to induce others to do so and that none of them had a realistic fear of being sued if they did so. In addition, the University of Utah moved to dismiss on the grounds that they could not be sued in New York.
The judge in the case rejected all of the defendant’s arguments. He ruled the plaintiffs did have standing to seek relief, and that the University of Utah shared responsibility for the actions of Myriad and therefore is a proper defendant. The judge also accepted the argument that the USPTO was an appropriate defendant due to the allegation that its policy is unconstitutional. Also notable was the fact that the judge not only permitted the scientific organizations, clinicians, and researchers to sue, but also allowed the genetic counselors, the patient advocate organizations, and the individual women to remain as plaintiffs in the case. The judge wrote, “The widespread use of gene sequence information as the foundation for biomedical research means that resolution of these issues will have far-reaching implications, not only for gene-based health care and the health of millions of women facing the specter of breast cancer, but also for the future course of biomedical research.”
Myriad, the University of Utah, and the USPTO were required to file a counter motion by December 23rd explaining why genes are not products or laws of nature in response to our motion for summary judgment. Oral arguments are scheduled for January 21st at 9 A.M. in New York.
More information and the full complaint are available at www.aclu.org/brca.
State News
Las Vegas Laboratory Program in Limbo
UNLV Administrators Look To Cut CLS Program To Ease Budget Woes
The University of Las Vegas (UNLV) is the latest university whose clinical science program (CLS) has been threatened with closure. As most states experience tight budgets, state university funds are being reduced, and administrators are looking for ways to trim costs. Unfortunately, for UNLV, their CLS program is high on the University’s list of programs to close. A decision is expected this month. The program, established in 1989, is the only CLS program in the state and according to its program administrators, its graduates boast a 100% pass rate on board examinations as well as 100% job placement within three months. ASCP will be working with those who administer the CLS program to shed light on the laboratory workforce shortage and the need for training programs that produce qualified laboratory professionals able to fill the current and anticipated future gaps in the workforce. Proponents of saving the school’s program assert that spending the money to maintain the CLS program is not only appropriate, but sensible because the program supplies laboratory personnel to Nevada and also to neighboring states. ASCP has gotten involved in numerous other campaigns to save CLS programs across the nation. ASCP is committed to the need to replenish the supply of qualified laboratory professionals. Updates about the UNLV program will be reported in future editions of ePolicy.
Reports
Integration, Efficiency, and Sustainability: New Strategy for AIDS Programs
A recently published report from Management Sciences for Health (MSH), entitled “Reversing the AIDS Epidemic through Third-Generation Health Systems: A Call to Action” emphasizes the need for AIDS programs to be centered on a united health systems response. According to MSH, now is the time to take a “systems approach” to HIV and AIDS programming because even with the success of past AIDS programs, prevention efforts still fail to reach people in countries most affected by the disease. Resource allocation for AIDS intervention is also threatened to decrease due to the effects of global financial crisis and provision for other major health needs. Therefore, a holistic, high-performing system that focuses on integration, efficiency, and sustainability is needed to ensure the success of future interventions.
The paper calls for donors, policymakers, and program managers in the public, private, and nongovernmental (NGO) sectors to take an active part in strengthening the health systems approach. Their participation is vital in that the six core components of the health systems for third-generation AIDS programs, namely, leadership, governance and management; health service delivery; human resources for health; pharmaceutical and laboratory management; health care financing and financial management; and health information, require their concerted efforts to change and improve. MSH also calls for polices that would stop discrimination in health care, as well as strategies to revitalize the primary health care framework to advance the impact of interventions. By changing the design and delivery of HIV and AIDS services, we would be closer to meeting the Millennium Development Goal of reversing the epidemic by 2015.
The publication of this report is timely in that it corresponds to the U.S. President's Emergency Plan for AIDS Relief (PEPFAR)’s new strategy for the global program: to make services a part of each nation’s health offerings. U.S. Global AIDS coordinator Eric Goosby said, “It is our honest belief that these programs are in a fragile period. We need to transition them into being more embedded in the countries’ infrastructure and for the countries to have true ownership of them.” The new direction for the program would handoff oversight of AIDS program to each countries’ health ministries with the goal that in the next five years, PEPFAR “will help treat 4 million infected people, care for 12 million, and double the number of babies born free of the virus.”
The laboratory community has the unique opportunity to make a large contribution to the Third-Generation AIDS programs by working with health systems to “prioritize strengthening laboratory infrastructure, not only to improve diagnosis but also to stem the development of drug resistance as more people are put on treatment.” Doing so will increase the quality of care, lower cost of service, and reduce waste. ASCP continues to promote strengthening of global laboratory services through quality education, mentorship, and collaboration.
For access to the MSH position paper, click here.