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ePolicy News May 2014

Tuesday, May 6, 2014




IOM to Study Diagnostic Error

An ad hoc committee of the Institute of Medicine’s Board on Health Care Services will evaluate the existing knowledge about diagnostic error in medicine from a patient safety perspective. The Committee on Diagnostic Error in Medicine will examine current definitions of diagnostic error (and illustrate examples); the epidemiology, burden of harm, and costs associated with diagnostic error; and what is being done to improve diagnosis. Sponsored by the Agency for Healthcare Research and Quality, the Centers for Disease Control and Prevention, as well as a variety of other non-governmental organizations, including ASCP, the study  will be a continuation of the IOM Health Care Quality Initiative, which includes the IOM reports To Err is Human: Building a Safer Health System (2000) and Crossing the Quality Chasm: A New Health System for the 21st Century (2001).

ASCP President Steve Kroft, MD, FASP, provided testimony at the kick-off meeting, urging the Committee to consider ways to “improve quality and safety by (1) enhancing the interface between the clinician and the laboratory to reduce testing-related errors that involve pre-analytic and post-analytic issues; (2) ensuring an adequately trained and certified laboratory workforce; (3) educating those that utilize laboratory services, both clinicians and patients, to realize our ultimate objective – to provide the right test to the right patient at the right time with the right result.” 

The Committee will develop recommendations to reduce diagnostic error in medicine. Action items for key stakeholders may focus on medical education, the culture of medical practice, information technology, systems engineering, measurement approaches, reimbursement policies, and further research. A study report will be released in late 2015.



CMS Releases Final Rule Allowing for Alternatives Sanctions for PT Referral

On April 30, the Centers for Medicare and Medicaid Services (CMS) issued a final rule providing the agency with greater flexibility over its handling of cases involving intentional proficiency testing (PT) referral. The new rule provides the agency with discretion with regard to substituting intermediate sanctions in lieu of the 2-year prohibition on the owner and operator when a CLIA certificate is revoked due to intentional PT referral, and to consider imposing alternative sanctions in lieu of revocation as well.

The final rule is in the concluding phase of a process called for by ASCP back in 2008 in a letter to CMS (Insert hyperlink here) urging the allowance of alternative sanctions for cases of accidental or inadvertent cases of intentionally PT referral. In that letter, ASCP wrote, “We find it troubling that CMS would employ a standard that would allow inadvertent or accidental referrals or the actions of a single staffer to result in the revocation of a CLIA certificate and, consequently, the application of a two-year ban on owning or operating a laboratory.”

The Clinical Laboratory Improvement Amendments (CLIA) of 1988 requires laboratories performing moderate or high complexity testing to enroll in an approved PT program. Any laboratory enrolled in a PT program, including those performing only waived testing, that intentionally refers its PT samples for analysis “risks having its certification revoked for at least one year, in which case, any owner or operator of the laboratory risks being prohibited from owning or operating another laboratory for two years.”

Under the final rule, CMS is dividing the sanctions for PT referral into three categories based on the severity and extent of the referrals. The first category is for the most egregious violations, encompassing cases of repeat PT referral or cases where a laboratory reports another laboratory’s test results as its own. In such cases, CMS would seek to revoke the CLIA certificate for at least one year, ban the owner and operator from owning or operating a CLIA-certified laboratory for at least one year and may also impose civil monetary penalties.

The second category of sanctions would result in the CLIA certificate being “suspended” or “limited” (rather than revoked), in combination with alternative sanctions. CMS would apply this type of sanction in instances in which a laboratory refers PT samples to a laboratory that operates under a different CLIA number before the PT event close date, and while the laboratory reports its own results to the PT program, it receives results for the second laboratory prior to the event close date. A suspension of the CLIA certificate would mean that no testing may be performed by the laboratory during the period of the suspension. This would usually only affect the laboratory in question rather than all laboratories under the control of the owner and operator. In contrast, a “limitation” of the CLIA certificate means that the laboratory is not permitted to perform testing or to bill Medicare for laboratory work in the specialty or subspecialty that has been limited.

The third category of sanctions will apply to those PT referral scenarios in which the referring laboratory “does not receive test results prior to the event cut-off date from another laboratory as a result of a PT referral.” Here, the laboratory would always be required to pay a civil monetary penalty and comply with a directed plan of correction, which would include training of staff. This category, as ASCP had hoped, would allow for lesser sanctions against a laboratory for inadvertent or accidental referral of PT samples.

Are Laboratories Completely Relieved of EHR Gifting Burden? OIG Advisory Opinion Suggests Not

OIG Releases Expert Advisory Opinion Shining Light on Lingering and Potentially Problematic Financial Arrangements 

While ASCP was extremely pleased that Electronic Health Record (EHR) gifting was deemed a violation of the Stark and Anti-kickback laws in December, a more recent Advisory Opinion posted by the Office of the Inspector General (OIG) in April identifies and addresses lingering referral-based arrangements that create “potentially problematic financial incentives” and pose “more than a minimal risk of fraud and abuse under the anti-kickback statute.”

The Advisory Opinion examines current arrangements involving referral-based laboratories offsetting the cost of EHR-Laboratory Information System (LIS) interfaces for referring clinicians. Accordingly, while laboratories have been prohibited from paying compensation (i.e., donating an EHR) to the clinician in exchange for referrals, they are still permitted to relieve clinicians from financial obligations and are, therefore, absorbing the vendor‘s interface transmission fees on behalf of the referring clinician in exchange for status as the clinician‘s “in-network‖ laboratory.” As such, the OIG stated that this arrangement “appears to permit Requestor [laboratory] to do indirectly what it cannot do directly; that is, to pay compensation to the Referring Physicians, by relieving them of a financial obligation, in return for the Referring Physicians’ laboratory test referrals.” The OIG subsequently concluded that though “this fee structure could potentially influence the Referring Physicians’ referral decisions in a material way… any definitive conclusion regarding the existence of an anti-kickback violation requires a determination of the parties’ intent, which determination is beyond the scope of the advisory opinion process.”

ASCP immediately exposed this type of arrangement in a recent comment letter to the Office of the National Coordinator (ONC), asserting that the designation of preferential laboratories limits EHR interoperability to in-office and/or in-network laboratories funding donor-specific interfaces. As such, the donor-specific interface functions only if specimens are referred to the donor‘s laboratory, rendering the patient information inaccessible to other health care providers within the patient‘s continuum of care. Hence, ASCP noted that this sort of “donor lock” is contradictory to ONC‘s previously stated belief that the EHR gifting safe harbor actually facilitates interoperability. The Society requested that ONC work within its authority to close this interface funding loophole and/or provide financial assistance for interface funding. Absent regulatory clarification that this practice is a direct violation of the Stark and Anti-Kickback laws, the creation of in-network laboratories may continue to inhibit robust health information exchange interoperability.


ONC Seeks Input on the Certification of non-EHR HIT Modules, Proposes to Align EHR Certification Criteria with CLIA Requirements

ASCP Questions Whether HIT Module Certification Will Lead to Pathologists’ Formal Participation in the Meaningful Use Program, Favors Integration of CLIA Requirements into EHR Certification Criteria 

On April 28, ASCP submitted formal comments in response to the Office of the National Coordinator (ONC)’s Proposed Rule, “Voluntary 2015 Edition Electronic Health Record (EHR) Certification Criteria; Interoperability Updates and Regulatory Improvements (RIN 0991–AB92).

In the Proposed Rule, ONC communicates its objectives to: better align certification requirements with the requirements of pay-for-performance programs and initiatives beyond the Meaningful Use (MU) program; integrate into interoperability standards existing health care delivery standards, such as those required by Clinical Laboratory Improvement Amendments (CLIA); and eventually incorporate Health Information Exchange (HIE) and interoperability requirements into payment and delivery system reforms. Also in the Proposed Rule are two key proposals aimed at enhancing the flexibility of certification requirements to better align with the pace and direction of the Health Information Technology (HIT) industry:

  • Voluntary Incremental EHR Certification: ONC proposes to enhance the frequency of federal rule-making to better align with the rapidly evolving HIT industry and extend options for voluntary, incremental EHR certification to provider entities that wish to keep pace with advances in industry standards.
  • HIT Module Certification: ONC proposes to move away from “complete EHR” certification and toward the certification of (EHR) HIT modules in an effort to better align with the varying rates of HIE advancement, the diverse selection of (non-EHR) information systems, and the unique needs of (specialty) providers across all possible health care settings.

In response to the Proposed Rule, ASCP recommended that ONC take the following actions to develop the regulatory foundation necessary for the achievement of widespread HIE interoperability:

  1. Recognize and reward the pathology and laboratory community‘s informational, operational, and financial contributions toward the MU of EHRs
  2. Increase the frequency of federal rule-making to obtain updated stakeholder feedback, keep pace with advances in industry standards, and extend more flexible/incremental compliance options
  3. Transition away from site-neutral certification requirements at the (EHR) system-level to site-specific certification requirements at the HIT module-level

    Important Note: The possibility of ONC certifying Laboratory Information Systems and the PQRS program’s Qualified Clinical Data Registries as HIT modules brings into question whether or not the MU program is evolving to enable/require pathologists to formally participate

  4. Ensure effective and efficient interoperability through the development of HIE/HIT standards that align and integrate with existing standards for other quality improvement and reporting initiatives (e.g. CLIA regulatory requirements)
  5. Enhance patient and provider access to accurate, robust and meaningful patient health information via geographically boundless, yet secure data portability

Also in the comment letter, ASCP stated that it would continue to offer guidance to the pathology and laboratory community regarding the provision of informational, operational, and financial support for the achievement of MU of EHRs. However, in the interim, the Society encouraged ONC to work with CMS and Congress to integrate quality initiative requirements to jointly recognize, regulate, and reward these efforts. ASCP further ascertained that absent financial and technical assistance, laboratories may not be able to sustain the costs nor adhere to the underlying HIE standards necessary for the development of a truly interoperable HIE system. Finally, the Society concluded that failure to capture laboratory test result data and leverage the role of the pathology and laboratory community threatens not just the achievement of an interoperable HIE system but also the secure, meaningful, and robust information sharing necessary to ensure patient-centered, value-based health care delivery and payment.

For a copy of ASCP’s Comment Letter to ONC, click here.


CMMI Seeks Input on the Role of Specialty Providers in Bundled Payment Models

ASCP proposes a bundled payment model that “creates an accountability infrastructure that promotes care coordination across the entire episode of care while recognizing the evidence-based, condition-specific variance in the standard time spent, services rendered, and resources consumed within each of the episode’s three separate service delivery segments: diagnosis, treatment, and care management.” 

On April 10, ASCP responded to the Center for Medicare and Medicaid Innovation (CMMI)’s Request for Information (RFI) on Specialty Practitioner Payment Model Opportunities. Unlike past bundled payment initiatives focusing on primary care and inpatient hospitalizations, the release of this RFI signifies CMS’s desire to test “new models of care that will focus on specific diseases, patient populations, and specialty practitioners in the outpatient setting to incentivize improved care, better health, and lower costs.”

ASCP appreciates that CMMI is exploring the idea of bundled payment initiatives to support quality, efficient, and coordinated delivery of outpatient services by specialty providers. Nonetheless, given that past bundled service initiatives have focused on chronic conditions and the inpatient setting, ASCP recognizes both the challenges and opportunities associated with establishing such a model for acute conditions that are not constrained within the walls of a hospital or the administrative boundaries of an Accountable Care Organization. In response to these challenges and opportunities, ASCP reiterated to CMMI the important role of pathologists and laboratory professionals in influencing and coordinating the delivery of quality and efficient care, regardless of the patient’s condition or the site of service delivery. Also in ASCP’s RFI response, the Society recommended the following key elements as crucial to the success of bundled payment initiatives for outpatient services:

  1. Leverage the Role of the Pathologist: ASCP recommended that bundled payment initiatives target procedures for which payment varies drastically (excluding variance based on patient condition/geography). Accordingly, though the delivery of diagnostic services has not been found to vary significantly, pathologists can help to mitigate any unnecessary payment variance in the delivery of treatment services by guiding appropriate utilization.
  2. Strategically Define the Episode: ASCP maintained that an accurate and fair bundled payment model would be double-sided and two-tiered, redistributing shared savings and losses at both the episode and episode-segment levels. However, it would involve the distribution of each of these two separate payments/penalties at the episode segment-level. As such the episode-level shared savings/losses would be weighted across each of the three segments to reflect varying accountability for patient outcomes.
  3. Carefully Operationalize the Episode: ASCP ascertained that careful operationalization of condition-based models will involve the establishment of the following at both the episode and the episode segment-levels: (1) Bundle Triggers; (2) Patient Attribution; (3) Administrative Oversight; (4) HIT Infrastructure Support; (5) Standard Clinical Protocols; and (6) Benchmarking and Risk-Adjustment.
  4. Encourage Participation: In order to encourage participation, ASCP suggested that providers will need to buy-in to both the policy and process underlying bundled payment model initiatives. The Society suggested that the policy create provider incentives to coordinate care/share accountability with non-affiliated provider (groups) while reinforcing provider confidence in its ability to fairly and accurately allocate risk across all providers involved in the episode of care. Similarly, ASCP asserted that an effective provider recruitment process for bundled payment model participation should be two-tiered involving: (1) the initial release of an RFI to gauge the data and resources needed by providers to implement the bundled payment model, followed by (2) the release of a detailed RFP based on the provider feedback resulting from the RFI.
  5. Assess and Regulate Impact on Service Delivery and Reimbursement: ASCP urged CMMI to ensure that bundled payment model initiatives do not incentivize the harmful self-referrals of anatomic pathology services. The Society warned that since clinicians are dis-incentivized to increase the quantity of services provided within a single bundle, they may very likely increase the quantity of bundles initiated. Additionally, ASCP stressed the importance of CMMI assessing whether facility-independent, condition-based bundled payment models result in any shifts in the care setting commonly associated with certain conditions. The Society further emphasized the importance of CMMI determining whether or not resulting shifts in care settings are positive or negative for patient access and cost.

To view ASCP’s Comment Letter in Response to CMMI’s RFI on Specialty Practitioner Bundled Payment Models, click here.

FDA Approves HPV DNA Test for Primary Screening

The U.S. Food and Drug Administration (FDA) has approved the first DNA test for the human papillomavirus (HPV) that could be used before or in place of the Pap smear for initial cervical cancer screening. The test’s approval expands the use of the test to include use as a primary cervical cancer screening test or as a co-test; however, it does not change current practice guidelines for cervical cancer screening, which are developed and reviewed by professional medical societies.

“Today’s approval offers women and physicians a new option for cervical cancer screening,” Alberto Gutierrez, PhD., director of the Office of In Vitro Diagnostics and Radiological Health at the FDA’s Center for Devices and Radiological Health, said in an FDA Press Release.  “Roche Diagnostics conducted a well-designed study that provided the FDA with a reasonable assurance of the safety and effectiveness when used as a primary screening tool for cervical cancer.”

The Cobas HPV Test detects DNA from 14 high-risk HPV types. The test specifically identifies HPV 16 and HPV 18, while concurrently detecting 12 other types of high-risk HPV strains. Women testing positive for HPV 16 or HPV 18 are to be referred for a colposcopy, while those testing positive for one or more of the 12 other high-risk HPV types should have a Pap test to determine the need for colposcopy. The FDA is recommending that health care providers use the patient screening history and risk factors, as well as current professional guidelines with the Cobas HPV test results, to determine best course of treatment for their patients.

In March, the Agency’s Medical Devices Advisory Committee Microbiology Panel concluded that the Cobas HPV test, developed by Roche Molecular Systems, is both safe and effective as a primary screening tool for cervical cancer. While the panel’s vote was unanimous, some members expressed reservations about using HPV testing as the sole screening tool as opposed to the current practice of co-testing. The Cytopathology Education and Technical Consortium (CETC), an independent consortium of professional organizations involved in diagnostic cytopathology, provided testimony to the advisory panel outlining a number of concerns that may potentially impact safety and efficacy for cervical cancer screening in the United States, should HPV primary screening gain FDA approval. ASCP, as well as the American Society of Cytopathology (ASC), the American Society for Cytotechnology (ASCT), the College of American Pathologists (CAP), the International Academy of Cytology (IAC) and the Papanicolaou Society of Cytopathology (PSC) are member organizations of the CETC.

Current U.S. guidelines recommend that women 30 to 65 undergo either co-testing with both HPV and Pap every five years, or Pap testing alone every three years. Women 21 to 30 are advised to have Pap testing every three years. Widespread adoption of the new test by clinicians will likely not take place until professional societies recommend it in guidelines, which could take years.



The SGR Patch and CLFS Revaluation

In the April edition of e-Policy, ASCP reported that Congress approved legislation on April 1 to extend the Sustainable Growth Rate (SGR) payment patch for one year. The move forestalled the then looming 24-percent cut in the Physician Fee Schedule (PFS) payment rates that would have gone into effect on April 1 had Congress not intervened.

ASCP was greatly disappointed with Congress’s failure to pass legislation to permanently repeal the SGR, which ASCP had strongly, and repeatedly, urged Congress to pass. The flawed SGR payment formula has caused massive disruption and uncertainly regarding Medicare physician payment rates, causing Congress to override the flawed formula on 17 occasions since 2003. In permanently repealing the SGR, ASCP had hoped that Congress would also reform the Stark Law by removing anatomic pathology from the in-Office Ancillary Services Exception and revise the upcoming Clinical Laboratory Fee Schedule (CLFS) revaluation that CMS had approved as part of its CY 2014 Physician Fee Schedule Final Rule, among other positive changes.

While disappointed with Congress’s inability to repeal the SGR and reform the Stark Law’s IOAS exception, ASCP appreciates that Congress shielded physicians from a 24-percent cut in payment rates by overriding the SGR (yet again) with a one year payment patch. In opting for a temporary fix, Congress also provided a 0.5 percent positive update in payment rates for the remainder of 2013.

Included in the SGR payment patch were provisions modifying CMS’s upcoming revaluation of the CLFS. While ASCP had been involved in the initial discussions around revamping CMS’s approach into a more transparent and structured process, the legislation approved by Congress represented a significant change from an earlier version. While ASCP supports provisions aimed at protecting vulnerable beneficiary populations, we are concerned about several provisions included in the final bill.

Importantly, Congress has provided a two-year delay in the revaluation of the CLFS, from Jan. 1, 2015 to Jan. 1, 2017. It has also included in the revaluation a phase-in requirement for any cuts in CLFS payment rates, with a maximum cut of 10 percent per year for codes revalued between 2017 and 2019, and a maximum 15-percent adjustment for codes revalued between 2020 and 2022.

Instead of trying to assess the extent to which technological change could be used to revalue laboratory payment rates, Congress moved forward with its desire to base payment rates on a market-based approach. This approach would require that CMS calculate payment rates based on the weighted median of private payer payment rates. As with the arbitrary technological change approach CMS had planned to use, this new approach is also expected to result in some significant payment cuts, but these changes should, at least in theory, be more transparent than they would have been had these codes be revalued on the basis of technological change.

Other changes include exempting CLFS payment rates from the annual update process. Given that most updates have been negative, due to productivity and other adjustments, this change may not be significant. Previously, any updates to the CLFS were reduced by several factors, including a productivity adjustment and a negative 1.75-percent adjustment mandated by the Affordable Care Act. Instead, Congress has not included an annual update to the fee schedule; however, in theory, an update could be factored into revised pricing during each annual revaluation period.

A big concern with Congress’s changes to the CLFS revaluation process is that the legislation imposes a reporting burden on billing entities. Under the plan enacted by Congress, applicable billing entities will be required to submit data every three years on the payment rates they receive from private payers and the volume of services associated with each payment rate. The reporting requirement will apply to those billing entities, such as clinical laboratories, with Medicare Part B revenue representing at least 50 percent of total Medicare payments to submit data. While CMS could set a volume or reimbursements-based threshold to exempt smaller laboratories from the reporting requirement, such an exemption may run counter to the interests of smaller laboratories, as the exemption would likely skew payment rates in a way that disadvantages laboratories that lack the economics of scale of larger reference laboratories. Indeed, a similar problem exists for hospital laboratories as it is unclear whether/how CMS could consider data at sites that receive reimbursement in the form of bundled and/or capitated payment rates from private payers. Another concern, CMS imposed a set of onerous penalties for non-compliance on the reporting requirements.

ASCP is strongly opposed to the reporting requirement and associated penalties. We believe these requirements place too heavy a burden on clinical laboratories and pathologists and are unrealistic. To be clear, this requirement affects only CLFS services and does not affect pathologists billing for services covered by the PFS. ASCP will be working with other professional associations representing the laboratory community to address these reporting burdens and other concerns addressed here.

Stark Reform Builds Momentum Once Again, CBO Estimates Major Savings while California Senate Takes a Vote

CBO Estimates $3.4 Billion in Cost Savings if Congress Enacted the President’s Budget Proposal to Close the In-Office Self-Referral Loophole

As previously reported, Congress failed to pass complete repeal of Medicare’s flawed Sustainable Growth Rate (SGR) payment formula and include Stark reform as a cost offset by April 1. Nonetheless, ASCP continues to advocate for the removal of anatomic pathology services from the in-office ancillary services (IOAS) exception to the Stark law and is pleased to report that momentum around this crucial issue is already building once again.

On April 17, the Congressional Budget Office (CBO) scored President Obama’s 2015 Budget Proposal and estimated cost-savings associated with the removal of certain complex ancillary services, including anatomic pathology services, from the IOAS exception at $3.4 billion. This represents an 89-percent increase over last year’s estimate ($1.8 billion), which did not include anatomic pathology services on the list of complex ancillary services to be removed from the IOAS exception due to a lack of published evidence at the time. Accordingly, this year’s cost-savings estimate reflects the removal of anatomic pathology, advanced imaging, radiation therapy, and physical therapy services from the IOAS exception to the Stark law. In addition to a number of reputable studies or reports recently published by the Government Accountability Office (GAO), the Medicare Payment Advisory Commission, and Health Affairs, this estimate further validates that the inappropriate self-referral of these complex ancillary services results in substantial and unnecessary expenditures for the Medicare program.

ASCP had reported in March that the Office of Management and Budget (OMB) released its cost-savings estimate of roughly $6 billion at the time of the release of the President’s 2015 Budget in February.  However, it’s important to note the following regarding that particular estimate:

  • This higher estimate out of OMB is due to the fact that OMB and CBO have different baseline projections regarding budget deficits and revenues. As such, it is inappropriate to compare the two amounts in a given year and instead more appropriate to compare the change in each amount from year to year.
  • OMB’s 2015 cost savings estimate associated with Stark reform has not yet been updated from its 2014 estimate, which did not include anatomic pathology services on the list of complex ancillary services to be removed from the IOAS exception. Accordingly, ASCP is working with our colleagues in the Alliance for the Integrity of Medicare (AIM) Coalition to urge OMB to update its cost-savings estimate as soon as possible to reflect the added savings associated with the proposed prohibition of self-referrals for anatomic pathology services.

ASCP has been advocating for the removal of anatomic pathology services from the IOAS exception for many years now. However, all of the recently published evidence suggesting that the self-referral of anatomic pathology services results in substantial overutilization, increased costs, and potentially harm to patients builds momentum around this issue like never before. The Society will continue to meet with Congress, urging them to pass legislation banning the harmful self-referral of anatomic pathology and other complex ancillary services inappropriately included under the IOAS exception.

California Senate Votes on Bill to Prohibit the Self-Referral of Complex Ancillary Services

On April 28, the California Senate voted on a bill (SB1215), introduced by State Sen. Ed Hernandez in late February, which aimed to prevent physicians in California from self-referring the anatomic pathology services they order on their patients. Specifically, the legislation sought to change the California state self-referral law’s in-office exception to bar clinicians from billing for self-referred anatomic pathology services as well as advanced imaging, radiation therapy, and physical therapy services.

ASCP joined the California Society of Pathologists in supporting SB 1215 and released an action alert asking our members to urge the California legislature to pass it. While the California Senate Business, Professions, and Economic Development Committee failed to pass the bill, ASCP is pleased that states are starting to take their own initiative on this important issue and is grateful to our members for responding to our action alert. ASCP will continue to support state-level efforts to prohibit the harmful self-referral of anatomic pathology services and respond accordingly.

Relevant Stark Reform Resources:


  • For ASCP’s Stark Reform Issue Brief, click here.
  • For ASCP’s Stark Reform Policy Statement, click here.

Associated Cost-Savings Estimates

  • For AIM’s Press Release regarding the CBO Budget Score, click here.
  • For ASCP’s Press Release regarding the inclusion of Stark Reform in the President’s 2015 Budget Proposal, click here.

California Senate Consideration

  • For a copy of the Senate Committee on Business, Professions and Economic Development’s April 28 Hearing Transcript, including arguments for and against amending California’s self-referral law to prohibit the self-referral of anatomic pathology services, click here.


Help Wanted: 2014 ASCP Vacancy Survey Launches

Every other year, ASCP conducts a crucial service for its members and the profession: the ASCP Wage and Vacancy Surveys. These surveys, conducted for the past 25 years, have become the primary source of information for academic, government, and industry experts in defining the state of the nation’s laboratory professional workforce.

This year, the ASCP began its 2014 Vacancy Survey of the laboratory professionals in the field. As in the past, the survey will seek to collect staff- and supervisory-level data, as well as recruitment and retention information in the laboratory workforce.

We encourage you to assist with this important study of the laboratory workforce.  Please forward the link below to the individual(s) in your laboratory responsible for hiring or staffing matters so that they may fill in vacancy information for the departments at your laboratory. 

Here is the link to the survey:

*The 2014 ASCP Vacancy Survey launched on April 17, 2014 and will remain open until May 19, 2014

Links to previous reports:

Lab Medicine Fall 2013 Edition (2013 ASCP Wage Survey)

Lab Medicine Winter 2013 Edition (2012 ASCP Vacancy Survey)



Deborah Birx, MD, Sworn In as New U.S. Global AIDS Coordinator

Dr. Deborah Birx was sworn in last month as the new Ambassador at Large and U.S. Global AIDS Coordinator to lead all U.S. government international HIV/AIDS efforts. Ambassador Birx now oversees implementation of the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR), the largest commitment by any nation to combat a single disease in history, as well as all U.S. government engagement with the Global Fund to Fight AIDS, tuberculosis and malaria.

Secretary of State John Kerry, presiding over the event, described Ambassador Birx as a tireless leader in the fight against HIV and “a pioneer as the first woman and first veteran to take this most high honor” as global AIDS coordinator.

Ambassador Birx began her career as a clinician in pediatric and adult immunology, focusing on clinical HIV/AIDS, vaccine research, and global health. She served as Assistant Chief of the Allergy Immunology Service at Walter Reed Army Medical Center and earned the U.S. Meritorious Service Medal for her leadership in refining, validating, and standardizing cell-mediated immunity testing in HIV-infected patients. During her military career, Ambassador Birx brought together the U.S. Navy, Army, and Air Force in a new model of cooperation increasing the efficiency and effectiveness of the U.S. Military’s HIV/AIDS clinical and basic research.

Since 2009, Ambassador Birx has served as the Director of the Division of Global HIV/ AIDS in the Center for Global Health at the Centers for Disease Control and Prevention (CDC). Her leadership galvanized support for laboratory strengthening initiatives across Africa, leading to accreditation and enhanced laboratory infrastructure, essential to quality and timely patient care.

Ambassador Birx assumes this role at a critical time for the PEPFAR. Her leadership will be essential in achieving the goals laid out in the PEPFAR Blueprint for Creating an AIDS-Free Generation. “If we begin to drift, lessen our aspirations, or leave behind science, we risk not only squandering the amazing investment made by American taxpayers, but also risk losing what we’ve already achieved,” she said. “We owe it to those who came before us and those who died to finish this job,” she added.

Ambassador Birx succeeds Ambassador Eric Goosby, who served as U.S. Global AIDS Coordinator between 2009 and 2013. Click here for Ambassador Birx’s statement regarding the principles of PEPFAR’s public health approach.


California Clinical Laboratory Association Sues HHS over Coverage

On April 18, the California Clinical Laboratory Association (CCLA) filed a lawsuit against the U.S. Department of Health and Human Services over the use of local coverage determinations (LCDs) by its Medicare Administrative Contractors. CCLA is suing over a concern that too much authority has been vested in the MACs with regard to the LCD process. The complaint alleges that the MACs are not following the required LCD process, resulting in coverage decisions that vary greatly by coverage area. Moreover, the compliant argues that HHS has created a process preventing clinical laboratories from appealing LCDs. In its complaint about the abuse of the LCD process, CCLA raises several examples pertaining to LCDs developed by Noridian and Palmetto GBA about coverage of molecular genetic testing and beneficiary access to these services.

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