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ePolicy News October, 2011

Thursday, September 29, 2011



ASCP Urges Congressional Deficit Super Committee
Find Permanent Medicare Payment Fix

ASCP is calling on Congress to find a permanent fix to the flawed sustainable growth rate (SGR), which could impose a 30-percent cut in physician reimbursement in 2012. Currently, the Congressional Joint Select Committee on Deficit Reduction is working to identify $1.5 trillion in budget cuts over the next 10 years. The Committee has until Nov. 23 to vote on its $1.5 trillion deficit reduction package.

In calling for a permanent fix, ASCP is joining its colleagues at the American Medical Association and other medical specialty societies. A 10-year fix to the sustainable growth rate (SGR) is estimated to cost $300 billion. Among the important reasons for a SGR fix is a budgetary imperative: In five years, a permanent fix would cost approximately $600 billion.

At this point, the Committee has not identified any particular policy options it is considering. That said, the Medicare Payment Advisory Commission (MedPAC), is considering a list of budgetary savings to help pay for an SGR fix. That proposal, outlined below, proposes cuts and freezes in physician specialist payment rates for the next 10 years, as well as a 10-percent cut in the clinical laboratory payment rates. To urge your members of Congress to find a permanent fix to the flawed SGR formula, please visit the ASCP e-Advocacy Center and send your elected representatives a quick message.

MedPAC Suggests Specialists, Laboratories Pay for Sustainable Growth Rate Fix

On Sept. 16, MedPAC, an independent agency providing advice and recommendations to Congress on Medicare policy, discussed a draft proposal that would require physician specialists and laboratories to pay part of cost for fixing the SGR.

The SGR is the formula used by the Centers for Medicare and Medicaid Services (CMS) to calculate the annual adjustments to Physician Fee Schedule (PFS) payment rates. The formula links the annual adjustments to the PFS to the differential between growth in total spending on physician services and the gross domestic product. Since the growth in spending on physician services regularly exceeds gross domestic product, the SGR formula indicates the need for cuts.

The cost of a 10-year SGR fix is estimated at $300 billion. At the urging of the group’s chairman, Glenn Hackbarth, the Commission discussed a proposal that would freeze reimbursement rates for primary care providers for 10 years while reducing reimbursement levels for physician-specialists by 5.9 percent annually for three years before freezing reimbursement rates for seven years. This would provide about $100 billion of the amount needed to pay for the SGR fix.

In addition, MedPAC has produced a draft list of offsets that are designed to provide the remaining $200 billion needed to pay for the SGR fix. Among these proposals, MedPAC suggests cutting reimbursement for laboratory tests reimbursed under the clinical laboratory fee schedule by 10 percent.

Deficit Reduction, Spending Cuts Potential Threat to Workforce Funding

Amid a continued failing economy, a mandate to reign in government spending and constituents clamoring to keep programs that benefit them afloat, Congressional leaders are engaged in a delicate balancing act. The Budget Control Act (P.L. 112-25), which was signed into law in August and allows President Obama to raise the debt ceiling, has a multitude of financial implications that threaten programs that fund workforce training. The magnitude of these implications could affect funding for workforce training over the next decade.

The Act includes two mechanisms for deficit reduction: it establishes caps on discretionary spending for fiscal years, FY 2012–2021, limiting how much Congress can appropriate for each year; in addition, the Joint Select Committee for Deficit Reduction, or the Supercommittee, has been tasked with developing recommendations for an additional $1.5 trillion in deficit savings. (See related story above). With the broad authority the Supercommittee has been granted, “nondiscretionary” programs must be considered at risk to be slashed.

During the first year of implementation, the only programs exempt from cuts are those related to defense such as homeland security and veterans. All other programs funding through Congressional action are subject to substantial cuts. These include job training funds under the Workforce Investment Act (WIA). Administered through the Department of Labor (DOL) with the intent of creating a universal access system of one-stop career centers, WIA would provide access to training and employment services for a range of workers. During the last several years, more than $5 million has been allocated for laboratory workforce training through the DOL’s WIA funds. ASCP continues to advocate for the reauthorization of WIA as a means of addressing the laboratory workforce shortage.

These measures coupled with conflicting actions in the House of Representatives and the Senate leaves a great deal of uncertainty about program funding. For example, the House passed nine spending bills with lower spending caps than the House budget resolution, yet the Senate maintained current levels for workforce programs when it considered the Labor-Health and Human Services (HHS) bill last month. In addition, President Obama’s recent introduction of the American Jobs Act, which includes monies for training investments, could be a vulnerable target.




Proposed Rule Requires Labs to Provide Patients with Test Results

On Sept. 14, CMS proposed requiring clinical laboratories to provide test results directly to patients. The proposed rule would amend the Clinical Laboratory Improvement Amendments (CLIA) of 1988 regulations to specify that, upon request, the laboratory must provide access to completed test reports. The rule requires laboratories to use their authentication processes to ensure that the individual requesting the test results is the patient.

The proposed rule would retain the existing CLIA provisions that provide for release of test reports to authorized persons and, if applicable, the individuals (or their personal representatives) responsible for using the test reports and, in the case of reference laboratories, the laboratory that initially requested the test. In addition, this proposed rule would also amend the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule to provide individuals the right to receive their test reports directly from laboratories by removing the exceptions for CLIA-certified laboratories and CLIA-exempt laboratories from the provision that provides individuals with the right of access to their protected health information.

The rule is being proposed, in part, because the agency believes “that the advent of certain health reform concepts (for example, individualized medicine and an individual’s active involvement in his or her own health care) would be best served by revisiting the CLIA limitations on the disclosure of laboratory test results.” The rule is also necessary to facilitate CMS’s Electronic Health Records (EHRs) Meaningful Use Regulations, which includes several metrics pertaining to patient access to laboratory test results. ASCP plans to comment on the proposed rule shortly.

Genetic Alliance Launches Vital Newborn Screening Resource

Baby’s First Test, developed by the Genetic Alliance with funding from the Genetic Services Branch of the Maternal and Child Health Bureau, Health Resources and Services Administration, and HHS, is an online newborn screening resource center specifically for parents and the public. The website is a result of the 2008 Newborn Screening Saves Lives Act, which provided funding to support research and education opportunities for newborn screening. Baby’s First Test will serve as a comprehensive guide for many aspects of newborn screening, including conditions covered and what to do in case of a screen positive test result. Sharon Terry, president and CEO of Genetic Alliance noted, “This site aims to support families by promoting earlier education about newborn screening. It will also provide a resource for healthcare providers to educate parents about what to expect after their baby is born.”

ASCP Submits Follow-up Comments on the NIH Genetic Test Registry

As part of ASCP’s continued effort in monitoring the development of the Genetic Test Registry (GTR), ASCP submitted a letter to the National Institutes of Health (NIH) indicating its concerns on the collection of information for the database. ASCP is concerned that the voluntary submission of data in the GTR with minimal or regulatory oversight could encourage certain genetic test manufacturers to use the registry as a marketing tool to promote their services. While ASCP supports the concept of the GTR, the quality, reliability, and safety of each diagnostic test submitted in the registry should prove scientifically valid and useful for clinical decision making.

In addition to asking for input on how to enhance the quality of the information to be collected, the NIH also asked for comments on whether the information entered in the database will have practical utility. Last fall, ASCP shared its views on the development of the GTR to the NIH stating that the agency take into consideration the best way to demonstrate the value of genetic tests for improving clinical outcomes through comparative effectiveness research.

ASCP continues to monitor the development of GTR. To view the written comments, click here



PEPFAR to Conduct Large Study of Combination Approaches to HIV Prevention

The U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) announced awards for a new initiative totaling $45 million over four years to examine the effectiveness of combination approaches to human immunodeficiency virus (HIV) prevention. Touted to be the largest and most robust to date, the studies will help partner countries strengthen their efforts to prevent new infections and save lives. Combination prevention uses a variety of mutually reinforcing interventions that target the risks of HIV transmission and acquisition thoroughly and strategically.

Announced at the PEPFAR Science Advisory Board Meeting last month, the studies will be critical to U.S. efforts to maximize the impact and efficiency of investments to save as many lives as possible. Ambassador Eric Goosby, U.S. Global AIDS Coordinator, commented, “In light of recent research establishing the preventative effect of antiretroviral treatment, antiretroviral-based interventions will be a key component of the combination approaches studied.” Set to begin later this year and continue through 2012, the studies will be coordinated by a body linked to the PEPFAR Science Advisory Board.



Requests for Rehearing of Myriad Lawsuit Denied by Federal Circuit Court

A Petition for Panel Rehearing of the Myriad gene patent lawsuit, filed by the American Civil Liberties Union (ACLU) on behalf of the Plaintiffs and Appellees, was denied last month. The petition alleged that both factual and legal errors were made in the court’s decision on both the standing and patent-eligibility issues, with the primary focus on the court’s interpretation of “isolated DNA.” Myriad also filed a petition for a rehearing that dealt with the issue of whether any of the plaintiffs in the case had the standing needed to continue. That petition was also denied.

The Plaintiffs and Appellees, which includes ASCP, plan to petition the U.S. Supreme Court to hear the case. While the Supreme Court hears very few cases, in recent months they have taken on other patent cases possibly indicating displeasure with the Federal Circuit. In addition, the novelty of this case itself may increase the likelihood of it being heard.


Laboratory Interoperability Use in Electronic Health Records

ASCP attended the Center for Disease Control and Prevention’s (CDC) Clinical Laboratory Improvement Advisory Committee (CLIAC) in Atlanta last month to hear updates from federal agencies and discussions on current issues facing field of laboratory medicine. Among the agenda items were presentations on the laboratory’s role in the development and use of EHRs, electronic laboratory reporting for notifiable diseases, and meaningful use; and current practices in gynecologic cytology testing. The highlight of the meeting, however, was the issues surrounding the laboratory’s role in the development and use of EHRs.

According to Jodi Daniel, JD, MPH, Director, Office of Policy and Planning, Office of the National Coordinator for Health Information Technology (ONCHIT), laboratory results and laboratory interoperability are important in the development process of the health information technology (HIT), because “clinical decisions are often influenced significantly by laboratory results and effective exchange of laboratory information will help reduce redundancy of effort and its associated cost.” One of the main problems discussed at the meeting was the difficulty of using EHRs in the laboratory community due to their insufficient external standards and requirements. Poor coordination of data could result in compromised patient safety and increased cost. More important, “pathologists and other laboratorians are usually not allowed to participate in the design, selection, implementation, and use of EHRs,” said David Booker, MD, Chair, Pathology Department, Trinity Hospital, Augusta, Ga.

ASCP acknowledges the tremendous benefit of further implementing health information technology into the healthcare delivery system. ASCP is committed to working with the government and other parties involved assuring that the use of EHRs and other forms of health information technology to guarantee quality medical practice and patient safety.



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