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ePolicy News July 2012

Thursday, June 28, 2012



Supreme Court Stuns: Upholds ACA, Including Individual Mandate
ASCP Will Continue Proactive Stance on Implementation of ACA

In a stunning victory for President Barack Obama, the U.S. Supreme Court upheld almost all of the President’s signature healthcare law, the Patient Protection and Affordable Care Act (PPACA), including its controversial individual mandate. In a decision that rocked the nation, the 5–4 decision, included the support of Chief Justice Roberts, usually a reliably conservative member of the court, along with Justices Ruth Bader Ginsburg, Sonia Sotomayer, Stephen Breyer, and Elena Kagen. Justice Anthony Kennedy, often a swing vote who many thought would decide the case, voted in the minority, which argued that the ACA is its entirety, not just the individual mandate, was unconstitutional.

The Court holds that the mandate is a valid part of the Federal government’s constitutional authority to levy taxes. Writing for the majority, Chief Justice John Roberts argued that the individual mandate is a tax. In essence, everyone must pay the cost of the tax, roughly $700 per year, but those who are insured are exempt from paying the tax. “In this case, however,” Roberts wrote, “it is reasonable to construe what Congress has done is increase taxes on those who have a certain amount of income but choose to go without health insurance. Such legislation is within Congress’s power to tax.” The Court did not agree with the Administration that the individual mandate was constitutional under the Constitution’s Commerce Clause, but did accept the Administrations backup argument that the mandate was a tax.

ASCP and its partners in pathology will remain proactive regarding the implementation of all of the various components of the health reform law and will continue to advocate for regulations that maximize the role that laboratory medicine can have to improve a patient’s health status. Some of the components where ASCP has been and will continue to be active include: accountable care organizations; meaningful use as it relates to the electronic health record; and the upcoming implementation of a proposal to bundle payments. Many of these elements of the law will continue to pressure the U.S. health system to be more performance based and move the system away from a pure fee-for-service model. This could change the reimbursement system dramatically, and ASCP will be proactive to ensure that quality laboratory medicine is available to improve patient outcomes.

The Court also upheld part of PPACA’s Medicaid provisions, which mandates states expand their Medicaid coverage and provides federal funds for part of the cost. The Court curtailed the provisions so only those states accepting the federal funds designated for expanded coverage must comply with the provision’s requirements. On this part of the landmark decision, Chief Justice Roberts wrote that Congress may not “penalize States that choose not to participate in that new program by taking away their existing Medicaid funding.”

The Supreme Court’s ruling clears the way for implementation of PPACA.


Gene Patent Case Heads Back to Federal Circuit Court

More than a dozen supplemental briefs were filed last month by the various stakeholders in the landmark case, Association for Molecular Pathology (AMP) v. U.S. Patent and Trademark Office (USPTO), in preparation for oral arguments in the case set for July 20 at the Federal Circuit Court of Appeals in Washington, D.C.

In March, the U.S. Supreme Court vacated the Federal Circuit’s endorsement of patents held by Myriad Genetics, a diagnostics company based in Salt Lake City and instructed the same three-judge panel that first considered the case to hear it again, this time with direction provided by the U.S. Supreme Court’s ruling in Mayo v. Prometheus Laboratories. In that case, the Court ruled that patents on a Prometheus blood assay were invalid because they simply reflected a “law of nature.” The debate in AMP v. USPTO centers on whether DNA isolated from the body is a product of nature, making it unpatentable. Myriad maintains that the isolated DNA is structurally and functionally different than DNA in the body.

Documents filed by the American Civil Liberties Union (ACLU) on behalf of the Appellees, including ASCP, describe their case against Myriad’s patents covering the BRCA1 and BRCA2 genes, which are associated with breast and ovarian cancer. Myriad Genetics also submitted amici, following a May 30 request that the Federal Circuit dismiss the lawsuit for lack of standing.

While a number of stakeholders filed briefs in support of each side, several were filed nominally “in support of neither party,” including one from the U.S. Department of Justice that argues that the Supreme Court’s decision in the Mayo v. Prometheus supports the invalidity of Myriad’s DNA claims.

Look for coverage of the hearing in next month’s ePolicy.




OIG Advisory Opinion Welcome News for Pathologists

Pathology isn’t the only medical specialty clinicians are trying to use as profit centers. Anesthesiology is also being targeted by clinicians dependent on medical services performed by other physicians or health providers. In June, the U.S. Department of Health and Human Services Office of Inspector General (OIG) advised that several arrangements designed to enable physician-owned professional corporations or limited liability corporations providing surgery/endoscopy services to secure all or part of the reimbursement provided by private insurance companies (non-Medicare patients) for anesthesia services could violate the federal anti-kickback statute. The arrangements involve the provision of anesthesia services provided at ambulatory surgical centers (ASC).

The first arrangements would grant the anesthesia services provider an exclusive contract to provide and bill directly for their services; however the provider would have to pay a per-patient management services fee to the physician owner/operators of the ASC—on patients not covered by federal healthcare programs. OIG noted it has “a long-standing concern about arrangements under which parties ‘carve out’ Federal healthcare program beneficiaries or business … from otherwise questionable financial arrangements.

The second arrangement involved the physician-owners of ASC establishing a separate subsidiary to provide the anesthesia-related services, engaging the anesthesia services provider, exclusively, as an independent contractor to provide anesthesia-related services. This arrangement raises concerns that the investments in ASC service as a vehicle to reward referrals. Interestingly, part of the rationale behind OIG’s opinion hinges on the fact that anesthesia-related services are not “surgical services,” which benefit from a safe-harbor. Similarly, pathology services are not considered “surgical services.”

Click here to obtain a copy of the OIG advisory opinion.


IOM Explores Acceleration of the Development of New Drugs, Diagnostics

The Institute of Medicine (IOM) held a workshop on the acceleration of the development of new drugs and diagnostics to advance translational sciences. Several initiatives were placed to create new paradigms for drug development and discovery, as well as partnerships between federal agencies, academia, and industry. The focus of the workshop is to maximize the impact and usefulness of the Cures Acceleration Network (CAN), authorized by the National Center for Advancing Translational Sciences (NCATS). The workshop objectives include:

  • Identify and catalog potential tools, methods, and approaches that hold promise for accelerating translational science;
  • Discuss the authorizations conferred on CAN and identify strategies for effectively using those authorizations;
  • Explore promising models for public-private collaborations that could be strengthened and facilitated under CAN; and
  • Identify barriers and potential solutions to facilitate coordination of activities under CAN with the FDA regulatory review process and timelines.

As a patient-centric organization, ASCP’s mission is to protect patient safety while promoting advances in medicine. The strategies that will be adopted must be sufficiently meticulous to safeguard the public without being so burdensome that it impedes the emerging advanced sciences.

For link to the workshop, go here.




TC Grandfather Provision Expires

On June 30, the technical component (TC) grandfather provision expired. The provision allowed independent clinical laboratories to bill for the technical component of a pathology service provided to hospital inpatients and outpatients. The provision primarily benefitted rural and underserved areas.

ASCP had joined with its partner, the College of American Pathologists, to resurrect the provision, but Congress was unwilling to extend the measure. Both ASCP and CAP urged Congress to permanently extend the TC provision. The TC grandfather was allowed to expire by Congress as part of a measure to reverse the sustainable growth rate-mandated cuts to the physician fee schedule. That measure not only has served to sunset the TC grandfather provision but also cut the clinical laboratory fee schedule by 2 percent.




ASCP Participates in New HIV/AIDS Policy Group

The Global AIDS Policy Partnership (GAPP) is a new, community-led platform by which members of the global HIV/AIDS community come together to share information, discuss legislative strategy, and develop consensus positions to present to policymakers and Members of Congress.

The first meeting of the GAPP convened on June 5 to deliberate on a formal charter for the group and to ensure that groups have the latest information on activities around the International AIDS Conference this July in Washington, D.C.

The creation of this new group serves as a vehicle for the HIV/AIDS advocacy community to decide how best to work together to advance the global HIV/AIDS agenda. The mission of the GAPP is to create not only a home for legislative and political discussions that advance common goals, but also to create a community dialogue around the scientific, social, and political issues that most affect people living with and affected by HIV around the world. 



ASCP Forms New Task Force on the Workforce

A new ASCP Task Force is currently being formed to recommend a comprehensive organizational strategy to address the future workforce needs of the nation’s clinical laboratories to continue to provide timely and safe patient care, and fully realize the benefits of personalized medicine. More than a decade ago, the ASCP Board of Directors established “workforce” as a Level I public policy priority. Data from several sources, including the 2010 ASCP Vacancy Survey, indicate a growing gap between the demand and supply for all professions of the laboratory team. For laboratory professionals, declining student enrollment, education program closures, and an aging workforce are contributing factors.

The U.S. Department of Labor projects that 11,000 medical laboratory professionals will be needed each year through 2018; approximately 5,000 students graduate each year from accredited training programs. Laboratory professionals represent one of the largest healthcare workforce groups as more than 330,000 medical and clinical laboratory technologists and technicians were employed in 2010, which exceeds the number of pharmacists, is more than four times the number of physician assistants, and five times the number of dieticians and nutritionists. On the physician side of the equation, the Health Resources and Services Administration has projected a major shortfall in the number of pathologists needed to fulfill the nation's growing demand for physician services.

ASCP’s current and ongoing initiatives on workforce development have shown measureable success and are well received by both the ASCP membership and the laboratory community at large. At this time, however, the coming convergence of a multitude of variables within both the workforce and the nation’s patient population coupled with numerous and rapidly occurring advances in the practice of medicine, warrant an in-depth comprehensive review. Periodic evaluation of the workforce landscape and the organization’s activities is an essential organizational function to fulfill ASCP’s role as a leader in the promotion of patient-centered care and the profession.


Healthcare Workforce Remains a Collective Concern

ASCP joined in a recent webinar to address the Healthcare Workforce. The event sponsored by the Bipartisan Policy Center Health Project and Deloitte Center for Health Solutions. A collective initiative, A 21st Century Approach to Health Workforce Planning, reflects an ongoing transformation of the healthcare system and what that means as the nation faces changing demands for healthcare professionals. Who will be providing our healthcare services in the future? Where? How?

The dramatic shifts in the healthcare marketplace necessitate the need to develop a national, comprehensive, and dynamic workforce planning strategy. Panelists indicated that this strategy must include better data and a better understanding of the healthcare professionals we currently have and will need in the future. Improved workforce projections are thought to lead to more effective federal and state policies.




Louisiana Defers Laboratory Personnel Standards Legislation

Earlier this year, ASCP supported legislation in the Louisiana House that would bolster the credentials required for licensure of laboratory professionals. HR 515, however, was involuntarily deferred in the House Health & Welfare Committee. The legislation is also supported by the Louisiana Society for Clinical Laboratory Science, the Louisiana Hospital Association, the Louisiana Pathology Society, the Louisiana Medical Society, and the Clinical Laboratory Personnel Association.


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