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ePolicy News December 2013

Friday, December 6, 2013



ASCP Members’ Voices Heard on CMS Physician Fee Schedule Payment Cap; CLFS Still Hit Hard

ASCP members’ voices were heard when they submitted more than 10,000 letters this fall to the Centers for Medicare and Medicaid Services (CMS) and Congress in opposition to CMS’ highly controversial proposal to cap Medicare payments for important life-saving diagnostic tests and procedures. Last week, CMS announced it would drop the proposal from its CY 2014 Medicare Physicians Fee Schedule (PFS).

However, the Society remains concerned about other aspects of the CY 2014 Physician Fee Schedule (PFS) Final Rule, including CMS’s plan to review and revalue all 1,250 codes on the Clinical Laboratory Fee Schedule (CLFS). ASCP is also concerned about a new policy to bundle outpatient physician and clinical laboratory services.

Steven Kroft, MD, FASCP, ASCP President and Vice Chair for Clinical Pathology and Director of Hematopathology at the Medical College of Wisconsin, said, “We are thankful that CMS eliminated the proposed cap, but are concerned that other decisions could disrupt the affordable supply of life-saving diagnostic services for patients.”


Cap on Physician Fee Schedule Payment Rates

Earlier this year, CMS had proposed to cap PFS payment rates that exceeded the hospital outpatient payment rates for the same service. Specifically, the proposal would cap technical component (TC) payment amounts for services provided in a “non-facility” setting (physician office and independent laboratory). CMS premised its proposed policy on the idea that, in general, non-facility settings have lower overall resource costs than facility settings, such as hospitals, and that paying more for services than the corresponding hospital outpatient rate was not appropriate.

ASCP was concerned that the proposal disproportionately impacted reimbursement for anatomic pathology services. Approximately 20 percent of the services affected by the cap would have been pathology services. Moreover, 38 of the 39 pathology services affected by the proposed cap would have been reimbursed at rates that failed to cover direct cost inputs, as is statutorily required. “This could result in reduced access to needed physician and laboratory services, inadequate compensation, and increased administrative burden,” Dr. Kroft said.

Dr. Kroft credited ASCP’s strong advocacy strategy in influencing CMS to remove this harmful proposal in the PFS Final Rule. In addition to meeting with CMS officials and speaking with Congressional staff about ASCP’s concerns with the proposed rules, the Society launched a highly successful grassroots campaign that generated more than 10,000 messages to CMS and members of Congress. Dr. Kroft also noted ASCP’s collaborative efforts with the College of American Pathologists (CAP), the American Clinical Laboratory Association, and others, in rallying Congress to generate 113 signatures in the U.S. House of Representatives and 40 signatures in the U.S. Senate on bipartisan letters voicing concern with the proposal to CMS.

ASCP is disappointed that the agency declared its intent to revise the proposed payment cap next year as part of the CY 2015 PFS Proposed Rule. ASCP will work with its coalition partners to monitor and respond to the proposal to ensure that payment rates for pathology services accurately account for the cost of delivering these services.


Revaluation of the CLFS to Account for Technological Change

Beginning next year, CMS will begin the process of revaluing the CLFS to account for technological efficiencies. The agency indicated that it will identify in its CY 2015 PFS Proposed Rule specific CLFS CPT codes it plans to revalue for the following year. CMS stated in its CY 2014 PFS Proposed Rule that it anticipated the process of revaluing the CLFS would take five years. To accomplish this, the agency would need to revalue approximately 250 of the 1,250 CLFS codes each year. However, because it has since altered its proposal and is allowing the public to nominate codes for revaluation through the formal rule-making process, the agency has not identified the number of codes that will be reviewed annually in the PFS Final Rule.

As justification for the change in payment policy, CMS noted that the CLFS’s “lack of an established mechanism to adjust payment amounts is unique among the Medicare payment schedules and systems.” CMS argued that the absence of an annual payment adjustment process “potentially results in CMS not paying accurately for [laboratory] tests.”

To identify and prioritize codes for review, CMS will conduct a data analysis of CLFS services. Previously, CMS had indicated that it would target those codes that have been on the CLFS the longest. In its PFS Final Rule, CMS modified its approach to identifying and prioritizing the codes for review. In addition to prioritizing codes that have been on the CLFS for the longest period of time, CMS will consider high volume test codes, codes with a high dollar payment amounts, and codes that have experienced rapid spending growth. ASCP is pleased that CMS is opening up the revaluation process to include stakeholder input through public nomination of codes to be reviewed during the formal rule-making process, as recommended by ASCP. Additionally, CMS stated in the PFS Final Rule that it would look to all sources, including insurance companies, for valuing each service.

ASCP raised a number of concerns about the proposal in discussions and correspondence with the agency. The Society is concerned that CMS was non-responsive to its recommendations that payment adjustment should be phased in over several years so that smaller laboratories or laboratories that offer only a small menu of tests would be minimally disrupted. ASCP also has lingering concerns that the revaluation process will based solely on the information provided by large laboratories, thereby generating values that are not appropriate for smaller independent laboratories.

ASCP is also pleased that CMS has acknowledged that “payment amounts could increase or decrease as a result of these reviews.” ASCP voiced concerns that much of the language in the PFS Proposed Rule seemed to suggest that adjustments would only be downward.


Bundling Physician and Laboratory Services into Hospital Outpatient Payment Rates

ASCP is also disappointed that CMS is implementing its proposal to include certain physician services and clinical laboratory services tests into hospital outpatient payment bundles. Currently, these services are paid separately under the PFS and CLFS. The policy change was noted in the PFS Final Rule, but was actually housed in the Hospital Outpatient Prospective Payment System (OPPS) Final Rule.

In its OPPS Proposed Rule, CMS stated it would bundle together more than 1,000 tests and services that are currently paid separately to the prospective payment “bundles” used in the OPPS. The agency contends that this policy would “contain unnecessary growth” in spending in the outpatient setting. CMS continues that the bundling policy applies to those tests that are “integral, ancillary, supportive, or adjunctive to a primary service provided in the hospital outpatient setting.” According to CMS, a laboratory test will not be bundled when it “is the only service provided to a beneficiary on that date of service.” The new policy will also not apply to molecular pathology services, which will continue to be paid separately.

In a comment letter to CMS responding to the OPPS Proposed Rule, ASCP expressed concern that this policy may result in inadequate payment rates and increased administrative burden on pathologists and clinical laboratories. ASCP also expressed concern with the proposal due to the scant information provided by CMS about the policy proposal’s details and likely impact. CMS did not respond to ASCP’s concerns about a lack of detail in the rule. It was this lack of information that raised concerns among providers that payment rates would be inadequate. However, CMS indicated that including laboratory services into the outpatient hospital payment bundles would reduce revenues to rural and teaching hospitals only modestly—probably less than one percent in aggregate.


Pathology-Specific CPT Code Changes

The PFS Final Rule also outlined a number of specific changes to payment rates for certain pathology CPT codes reimbursed under the PFS.

Immunohistochemistry: CMS has declined to accept the recommendations of the American Medical Association (AMA) Current Procedural Terminology (CPT) Committee, which revised the descriptor for CPT 88342 and created a new add-on CPT code 88343 for CY 2014. Instead, CMS has created two new G codes: G0461 (Immunohistochemistry or immunocytochemistry, per specimen; first single or multiplex antibody stain) and G0462 (Immunohistochemistry or immunocytochemistry, per specimen; each additional single or multiplex antibody stain (List separately in addition to code for primary procedure) to ensure that the services are only reported once for each antibody per specimen. CMS did accept the AMA Specialty Society Relative Value Scale Update Committee (RUC) recommendation on valuing these services. In establishing the G-codes, it appears that there may be a technical issue related to the G-code as CMS used several different descriptors for the new codes. ASCP will be in contact with CMS to clarify the appropriate descriptors to be used.

88305 TC: One issue outstanding for CPT code 88305 TC was whether CMS would further reduce the payment amount for the CPT code 88305 TC. As part of last year’s final rule, CMS noted that it had heard from one stakeholder suggesting that this service was overvalued. As part of the agency’s revaluation of 88305, it questioned the number of slides typically examined as part of performing this service. To assist with this process, CAP provided data to the RUC on the number of slides involved in the examination process. The data provided by CAP and supported by the RUC (and ASCP) was consistent with CMS’s understanding of the work load involved. ASCP is pleased to report that CMS has accepted the CAP/RUC recommendations, meaning no further reductions for the TC payment were announced pertaining to the number of slides reviewed.

Quality Reporting Programs and the Value-Based Payment Modifier

Physician Quality Reporting System (PQRS)

PQRS is a pay-for-reporting program that uses a combination of incentive payments and downward payment adjustments to promote reporting of quality information by eligible professionals (EPs). Since the program’s establishment in 2007, CMS has distributed incentive payments to incentivize providers to successfully report on specified quality measures. However, beginning in 2015, CMS will cease distribution of incentive payments and instead begin to enforce payment adjustments for physicians that qualify for PQRS, but are unable to successfully report on quality measures. The payment adjustment will initially be based on -1.5 percent of the individual physician’s total, annual Medicare Part B-covered professional services, but will increase to -2 percent for 2016 and subsequent years.


2014 PQRS changes that may negatively impact pathologists:
  • No New Pathology-Specific Measures Adopted for 2014: While CMS is adding 57 new individual measures and two measures groups, it rejected the three pathology-specific measures proposed for adoption by the College of American Pathologists (CAP), which were strongly supported by ASCP, and neglected to add any pathology-specific measures for 2014.
  • Shift away from Claims-based Reporting: CMS is retiring a number of claims-based measures to encourage reporting via registry and EHR-based reporting mechanisms.
  • Increase in the number of measures required to qualify for a 0.5 percent incentive payment in 2014: CMS finalized its proposal to increase the number of measures EPs would be required to report for the 2014 PQRS incentive from three measures covering one NQS domain to nine measures covering three NQS domains on 50 percent of its applicable patients.
  • Elimination of the CMS-calculated administrative claims-based reporting mechanism: The administrative-claims based reporting option, initially established in CY 2013 as an additional route to avoiding the CY 2015 payment adjustment, will no longer be available in CY 2014 for avoidance of the CY 2016 payment adjustment. ASCP requested continuation of this option, which was the least administratively burdensome option for avoiding the payment adjustments.


2014 PQRS changes that may positively impact pathologists:
  • Flexibility around number of measures required to avoid negative payment adjustment: CMS finalized the criterion that EPs must report on three measures on 50 percent of its applicable patients for the 2016 PQRS payment adjustment. However, CMS is allowing EPs to report on as many (1-3) measures as are applicable to its practice. CMS is also eliminating the requirement that one of the three measures must be an outcome measure for 2016, but will reintroduce the requirement in 2017.
  • Flexibility around number of measures required to qualify for an incentive payment: CMS will allow EPs that do not have nine applicable measures to qualify for an incentive by reporting on as many measures (1-8) covering as many NQS domains (1-3) as are applicable to his/her practice and for which there is Medicare patient data.


2014 PQRS Changes for which impact on pathologists is unclear
  • PQRS Reporting via Satisfactory Participation in a Qualified Clinical Data Registry: The American Taxpayer Relief Act of 2012 allows EPs to be treated as satisfactorily submitting data on quality measures for covered professional services if the EP satisfactorily participates in a qualified clinical data registry. Under this option, EPs report the data on quality measures used by the qualified clinical data registry, including non-PQRS measures. EPs may also report measures on all patients, regardless of whether or not they are Medicare Part B FFS patients.


The Value-based Payment Modifier

The Affordable Care Act mandated that, by 2015, CMS begin applying a value modifier under the PFS to facilitate upward and downward payment adjustments to physicians based on both the cost and quality of the care that they provide to their patient population covered under Medicare FFS.

Requirements for the 2015 VBM were finalized in the CY 2013 PFS Final Rule, since the VBM’s value is dependent upon physician performance in CY 2013. Specifically, medical practice groups (defined at the tax identification number-level) of 100 or more EPs must register and participate in PQRS as a group in order to avoid a negative one percent payment adjustment (in 2015) under the value modifier. For the CY 2015 VBM, physicians could elect a quality-tiered option based on quality and cost performance in CY 2013. Accordingly, physicians could qualify for a positive or negative payment adjustment. While the adjustment amount is based on one percent of the EP’s Medicare Part B charges in CY 2013, it would not be applied until CY 2015.

Similarly, requirements for the 2016 VBM were finalized in the CY 2014 PFS Final Rule, since the VBM’s value is dependent upon physician performance in CY 2014. CMS established the following changes to the VBM for 2016:  

  • Lowers Groups Size Threshold for Application of the VBM: The VBM that was previously only applied to groups of 100+ EPs will begin to apply to groups of 10 to 100 EPs.
  • Allows a 50-Percent PQRS Group Participation Threshold for fulfillment of VBM: While the 2015 VBM required that EPs report under PQRS as a group, the 2016 VBM requirements may be fulfilled if 50 percent of EPs within a group individually fulfill reporting requirements for avoiding the CY 2016 PQRS payment adjustment.
  • Introduces Mandatory Quality-Tiering: Quality “tiering” was previously optional and now it is mandatory, although groups of 10 to 100 EPs are protected from downward payment adjustments in 2016.
  • Introduces the Medicare Spending Per Beneficiary Measure (MSPB): The composite cost measure includes all Medicare Part A and Part B payments during an MSPB episode, spanning from three days prior to a hospital admission to 30 days post-discharge. While CMS initially proposed to attribute an MSPB episode to a group of physicians if any EP in the group bills a Medicare Part B claim during the patient’s hospital admission, it finalized an attribution methodology based on the plurality of services provided during an MSPB episode.
  • Refines the Cost Measure Benchmarking Methodology to Account for Specialty Mix: CMS examined the distribution of the cost composite scores among all groups of physicians and solo practitioners to determine whether comparisons at the group level are appropriate. CMS found that its current peer grouping methodology could have varied impacts on different physician specialties and therefore proposed specialty type adjustments when comparing physician group performance accordingly.
  • Increases the Payment Amount at Risk: CMS is increasing the maximum downward adjustment under the value-based payment modifier from 1.0 percent in CY 2015 to 2.0 percent for CY 2016.  


ASCP’s primary concern regarding CMS quality reporting programs is that they simply do not align with the unique traits innate to the pathology specialty, such as its lack of face-to-face patient interaction, its referral-based nature, and its commonly hospital-based environment. As such, the Society has recently submitted a proposal to CMS with a recommendation for an alternative means of fulfilling PQRS requirements. ASCP hopes to schedule a meeting with CMS regarding this proposal and will report back to the Society’s members accordingly.

Nonetheless, ASCP is extremely disappointed that CMS failed to approve additional pathology-specific PQRS measures, especially because the payment at risk under PQRS is increasing with the implementation of the VBM. However, the Society is grateful that CMS will continue to allow reporting on at least one applicable PQRS measure in fulfillment of PQRS requirements for an incentive and avoidance of a payment adjustment. ASCP will continue to support any viable PQRS measures developed by the CAP and will assess whether reporting via qualified clinical data registries creates the opportunity to develop and report on pathology-specific measures not formally approved by CMS.

To obtain a copy of ASCP’s comment letter on the PFS Proposed Rule, submitted jointly with the American Pathology Foundation, click here.

To obtain a copy of ASCP’s comment letter on the OPPS Proposed Rule, click here.  


Regs on their way…  

The ASCP Washington, D.C., office constantly monitors legislation and regulations relevant to the pathology and laboratory community at various stages in the developmental process. The following is an overview of a few regulations ASCP anticipates will be released in the near future.

EHR Gifting
Currently under review by the Office of Management and Budget are two final rules related to the gifting of Electronic Health Records in exchange for referrals. Proposed Rules were released April 10, 2013. The first rule was proposed by the Center for Medicare and Medicaid Services (CMS) in effort to extend the sunset date of the Stark law/self-referral exception for the donation of EHR items and services from Dec. 31, 2013 to Dec. 31, 2016. Similarly, the Office of the Inspector General (IOG) published its own rule extending the sunset date to Dec. 31, 2016 for the EHR Safe Harbor under the Federal Anti-kickback statute.

ASCP is opposed to both of these harmful exceptions and does not support their extension. The Society views EHR gifting in exchange for referrals as a direct violation of both the Stark law and the Anti-kickback law. While pathologists and laboratories are unable to participate in the EHR Incentive Program, they are increasingly expected to gift EHRs to clinicians that are eligible to participate in the EHR Incentive program in exchange for referrals. Hence, they must weigh the cost of purchasing and maintaining an EHR for each of their referring clinician practices with the cost of losing incoming business from each of those practices.

The Secretary of the Department of Health and Human Services estimates that the cost of an EHR per clinician is approximately $54,000 for the first year and $20,610 for subsequent years. Worse yet, these prices do not include the cost of each EHR interface, estimated at roughly $5,000 each. According to the safe harbor provisions established in 2006 under the federal anti-kickback statute, pathologists/laboratories may contribute up to 85 percent of the cost of the EHR. In consideration of the Secretary’s per-clinician estimates, costs accrued can really add up for a laboratory referred by multiple clinician offices with multiple clinicians staffing each office. Hence, these substantial added costs may threaten the affordable supply of laboratory tests and pathology services.

Most recently, ASCP outlined these and other concerns related to EHR gifting to CMS in the “The Electronic Health Record (EHR) Incentive Program” section, on pages 14-15, of the Society’s CY 2014 Medicare Physician Fee Schedule comment letter, submitted jointly with the American Pathology Foundation.

Direct Access to Laboratory Test Results
Another rule under review by OMB provides patients with direct access to their laboratory test results upon request. ASCP supported the rule when it was proposed in 2011, saying in a comment letter, “As a patient-centric organization, ASCP strongly supports [CMS’s] efforts to empower patients by encouraging them to obtain and understand their personal health data. Patients pay for the cost of laboratory testing; they have a right to this information.”

ASCP also stated, “We are concerned about the prospect of patients ‘interpreting’ their own results without contacting their physician. For this rule to work from an operational perspective, we believe that patients will need to either seek their results directly from their physician or have the physician identify the appropriate clinical laboratory.” ASCP also argued that “clinical laboratories should have the ultimate authority to determine the processes they will use to execute the requirements of the final rule.” ASCP also urged CMS to allow laboratories “to recoup the costs of research and retrieval of archived records.”

The rule is apparently necessary because of conflicting state laws regarding patient access to their test results. Currently, 24 states do not have a state law specifying authorized recipients of tests reports while 13 states allow test reports to be released only to providers. Only 15 states allow test results to be released to patients, but seven states allow it only when approved by the patients’ physician.

Recently, CMS and the Office of the National Coordinator (ONC) for Health Information Technology (HIT) asserted that inhibiting direct patient access to their own records is contradictory to recent health reform-driven initiatives, such as individualized medicine, consumer-directed health care, and widespread adoption of EHRs. As such, this rule proposes revisions to CLIA to provide patients, upon request, with direct access to their laboratory test reports. Specifically, upon a patient’s request, this rule would allow the laboratory to provide an individual with access to his or her completed test reports that, using the laboratory’s authentication processes, can be identified as belonging to that patient.

ASCP’s comments on the proposed rule were based in part on the Society’s official Policy Statement on Direct Access Testing. In that policy statement, ASCP observes that the ordering physician has access to the patient medical history, which is important to proper test interpretation And that patients are best served by consulting their physician on the proper interpretation of test results.,

ASCP will continue to monitor the OMB cue and notify members immediately upon publication of these three Final Rules.




Count Down to the New Year….SGR Repeal Legislation or Bust
(Temporary Payment Patch)!

On Nov. 12, 2013 ASCP submitted a formal comment letter in response to the Sustainable Growth Rate (SGR) repeal framework discussion draft, released jointly by the Committee on Ways and Means in the U.S. House of Representatives and the Finance Committee in the U.S. Senate. ASCP is a staunch supporter of complete SGR repeal, which the Society believes will reinforce the sustainability of the Medicare program while easing provider payment and patient access concerns. However, ASCP remains cautious about SGR repeal proposals as some may contain provisions that may not be in the best interest of the pathology and laboratory community or patients. As such, the Society communicated to Congress that successful and complete SGR repeal must be accompanied by the following:

Annual updates for health care cost inflation. The SGR payment update mechanism, which aimed to align physician spending with general cost inflation, failed because it did not recognize health care as a unique good with unique supply, demand, and cost growth. The Society maintains that inflation updates are necessary, but that they simply must be in line with the economic drivers unique to the health care industry. Accordingly, ASCP disagrees with this framework’s proposal to accompany SGR repeal with zero percent updates through 2023. Absent adjustment for health care cost inflation, the value of certain services may not hold, thereby threatening the affordability and therefore feasibility of supplying these services.

Fee-for-Service (FFS) payment system reform and Stark reform, including the removal of anatomic pathology services from the in-office ancillary service (IOAS) exception to the Stark Law. ASCP supports FFS payment system reform because it believe the current system inappropriately incentivizes and rewards value over volume. The Society supports Stark reform because it believes the IOAS exception inappropriately includes anatomic pathology services, thereby allowing for harmful self-referral of these services and driving up utilization and costs accordingly. However, ASCP specifically proposes these two reform initiatives in conjunction with SGR repeal because of their combined ability to reduce overutilization and unnecessary utilization, control costs, and thus regulate health care cost inflation. As such, they have the joint capacity to bring health care cost inflation more in line with general inflation, deeming it a more conservative and appropriate annual adjustment factor for physician payment.

A pay-for-performance system that is feasible, robust, and risk-adjusted to include and accommodate all specialty types. ASCP has significant concerns with this framework’s proposed Value-Based Performance (VBP) Payment Program, which seems to merely combine existing quality reporting programs without a detailed plan for significantly improving them. The Society is concerned that pathologists will not qualify for three of the four proposed assessment categories. Pathologists still do not have enough applicable PQRS measures, they lack the capability to directly control utilization, and they remain unable to participate in the EHR Incentive program. However, ASCP voiced support for the new quality assessment category proposed, clinical practice improvement activities. The Society believes this category has the potential to better capture pathologists’ broad quality-improvement efforts already occurring.

Transition to alternative payment models (APMs), such as Accountable Care Organizations (ACOs), Patient-Centered Medical Homes (PCMHs), and bundling initiatives: ASCP strongly supports the idea of encouraging greater participation in these APMs, particularly as an alternative means of satisfying the VBP requirements. The Society expressed its support for an initial one-sided risk model, with eventual transition to a two-sided risk model as participation in APMs increases. The Society also expressed its support of a 25-percent Medicare revenue threshold to qualify groups of physicians as eligible for APMs, cautioning that higher thresholds may incentivize overutilization and unfairly disqualify providers in certain geographic markets for reasons outside their control. Lastly, the Society reiterated the importance and applicability of Stark reform to bundled payment initiatives, which have the capability to generate harmful self-referral practices, overutilization, and unfair payment tactics, such as fee-splitting and price mark-ups.

An appropriate mechanism for ensuring accurate valuation of payments: ASCP supports CMS efforts to ensure accurate valuation of payments, but does not support this framework’s proposed mandate for annual CMS review of codes totaling one percent of all Medicare Part B charges for years 2015 through 2017. CMS has already reviewed $76 billion of the $87 billion in spending under Medicare Part B. ASCP notes this leaves only $10 billion worth of services left to be reviewed. In order to meet the annual one-percent target, nearly all of the remaining codes would need to be reviewed in the first year. Given that only a large quantity of low-volume codes remains, revaluation of codes in year two and three would require revaluing codes that have already been accurately revalued. As such, ASCP encouraged removal of the Medicare spending threshold for annual review of potentially misvalued codes and proposed the requirement that CMS ensure downward smoothing of payment adjustments over several years.

Absent Congressional action by Jan. 1, a roughly 24 percent reduction in physician reimbursement is set to take place as a result of the SGR payment update mechanism. Currently, the Senate Finance Committee is scheduled to mark-up legislation, based on the SGR repeal framework, on Dec. 12. The Ways and Means Committee has not yet scheduled a mark-up on the framework. If it opts not to do so, it may modify legislation already passed by the House Energy and Commerce Committee by a 51-0 bipartisan vote on July 31, 2013. There are multiple avenues for SGR repeal legislation movement in Congress at this stage.

If Congress cannot pass SGR repeal legislation this year, they will likely opt for a temporary payment patch in effort to avert the 24-percent Medicare payment cuts across the board at the onset of the new year. Congress has opted for this short-term payment patch approach since 2003, when the SGR began calling for negative payment adjustments. Nonetheless, the talk on Capitol Hill is that we could be one or two payment patches away from complete SGR repeal. This means many believe it could happen in 2014! ASCP will continue to update our members accordingly.  



PEPFAR Stewardship and Oversight Act Passes Congress and is Signed into Law

With strong bi-partisan support, both the House and Senate approved an extension of a program established by former President George W. Bush to fight HIV/AIDS and other diseases abroad. The measure will reauthorize the President’s Emergency Plan for AIDS Relief (PEPFAR), a federal aid program established in 2003 that has provided assistance to more than 46 million individuals, including orphans, vulnerable children and women, and provided funding for AIDS research. The program has focused billions of dollars to build health system infrastructure and provide nearly six million people with anti-retroviral drugs.

The PEPFAR Stewardship and Oversight Act (S.1545), introduced by Senators Robert Menendez (D-N.J.) and Bob Corker (R-Tenn.), modifies and extends the authorities of the 2003 legislation that initiated the PEPFAR program. While the bill does not explicitly renew authorization of PEPFAR, by extending “authorities related to global HIV/AIDS” it could protect the program from Congressional challenges against appropriating funding without authorization. In addition, by seeking to “promote oversight of United States Programs,” it implies those programs will continue to exist with their current missions. The bill also contains provisions for orphans and vulnerable children authorized by PEPFAR, extending the 10 percent of funding allocation for those populations and the requirement that at least 50 percent of the funding be allocated for treatment, care and support, through 2018. The bill calls for a plan for conducting cost studies of assistance to “partner countries,” expenditure analyses by partner countries, and defines “partner countries” as those receiving at least $5 million annually in U.S. funds for HIV/AIDS responses. An identical companion House bill (H.R. 3177) was introduced by Representatives Eliot Engel (D-N.Y.), Ed Royce (R-Calif.), Barbara Lee (D-Calif.), and Ileana Ros-Lehtinen (R-Fla.).

Acting U.S. Global AIDS Coordinator Deborah von Zinkernagel who assumed the position following the departure of Eric Goosby, MD*, from that post, commended Congress’s swift action, saying, “The passage of the PEPFAR Stewardship and Oversight Act demonstrates the United States’ sustained commitment to fighting this deadly disease, but the U.S. cannot do it alone. Achieving an AIDS-free generation is a shared responsibility. We are profoundly grateful to Congress for its leadership in ensuring our path and our purpose in the global fight remains strong.”

President Obama signed the bill into law earlier this week.

*ASCP joined 33 other organizations of the Global AIDS Policy Partnership (GAPP) in thanking and congratulating Ambassador Eric Goosby for his years of service leading the PEPFAR program. Under his leadership, PEPFAR has made unprecedented progress in expanding the reach of antiretroviral treatment and other life-saving services to millions in developing countries.




ASCP Co-Sponsors Workforce Summit

This week, representatives from over 24 organizations representing pathology, laboratory medicine, and medical education gathered in Washington, D.C., to discuss the future of the profession. The 2013 Pathology Workforce Summit, sponsored by ASCP, the College of American Pathologists (CAP), the Association of Pathology Chairs (APC), and the United States & Canada Academy of Pathology (USCAP), convened to consider how the profession must evolve to meet the needs of both a specialty and a healthcare system poised for dramatic transition.

A number of factors are projected to profoundly impact both the supply of pathologists and non-physician laboratory professionals as well as the demand for pathology and laboratory services. On the supply side, the profession faces challenges of recruitment, retention and pending retirements. On the demand side, the convergence of profound shifts in population demographics, legislative and regulatory reforms, and major advances in medical diagnostics and treatments, will be significant influences. Some think these factors will create an unprecedented demand for services, while others believe the demand will be tempered by more efficient utilization. Robust discussions by participants around these key issues identified common objectives regarding workforce development and revealed many opportunities for collaboration. As ASCP President Steven Kroft, MD, FASCP, said in his opening remarks, “Not everyone will agree on everything. However, what I think we can all agree on is that it is vital that the profession come together to meet the challenges ahead of us.”

For ASCP, the Summit comes on the heels of year-long examination of workforce issues. Earlier this year ASCP hosted a Pathologist Workforce Roundtable. In September, the Task Force on the Laboratory Professionals Workforce published Building a Laboratory Workforce to Meet the Future. While the Summit participants were primarily pathologist organizations, both physician and non-physician pathology and laboratory professions were addressed in the discussions. Dr. Kroft noted that “ensuring a vital future for pathology and laboratory medicine requires developing workforce strategies that create teams prepared to meet future challenges.”

In addition to the sponsoring organizations, participants included:
Academy of Clinical Lab Physicians & Scientists
Accreditation Council for Graduate Medical Education
Pathology Residency Review Committee
American Association of Neuropathologists
American Board of Oral & Maxillofacial Pathology
American Board of Pathology
American Medical Association
American Pathology Foundation
American Society for Investigative Pathology
American Society of Cytopathology
American Society of Dermatopathology
Association for Molecular Pathology
Association for Pathology Informatics
Association of American Medical Colleges
Association of Clinical Scientists
Association of Directors of Anatomic &Surgical Pathology
Association of Pathology Chairs/Residency Program Directors
Canadian Association of Pathologists
National Association of Medical Examiners
Society for Hematopathology
Society for Pediatric Pathology

More details on outcomes of the Summit to follow in upcoming issues of ePolicy.  


ASCP Urges Congress to Protect GME Financing

ASCP joined the Graduate Medical Education (GME) Advocacy Coalition in urging all members of Congress to protect Medicare beneficiary access to healthcare services by preserving existing Medicare financing for Graduate Medical Education. Reductions in Medicare support for GME could worsen an already critical national physician workforce shortage and limit teaching hospitals’ ability to maintain essential life-saving services.

Medicare’s current gap on financial support for GME prevents teaching hospitals from expanding the number of training positions and often prevents new hospitals from establishing teaching programs. There is a dire need to invest in physician training programs, not reduce support, as such cuts to Medicare GME financing could potentially exacerbate the physician shortage at a time when an estimated 10,000 Americans are turning 65 each day, while one in three practicing physicians plan to retire by 2020.

The Association of American Medical Colleges and others predict a shortfall of 91,500 physicians (including 46,100 specialists) by 2020. New and existing medical schools have responded by expanding enrollment, but without sufficient residency opportunities, these new physicians will not be able to practice. Cuts to Medicare GME threaten to bottleneck the pipeline and jeopardize access to care across the country, particularly in areas that are already underserved.

ASCP will continue to closely monitor GME financing and will report developments in ePolicy.


Restructuring the Healthcare Workforce to Adapt to the Future Demand for Healthcare Services

Redesigning the healthcare workforce discussion took center stage at the health policy briefing coordinated by Health Affairs and Academic Medicine in Washington, D.C. With the Affordable Care Act’s (ACA) expanded coverage and future demographic changes, the nation’s supply and demand for healthcare practitioners has been put into question. According to the Association of American Medical Colleges (AAMC), there will be “45,000 too few primary care physicians, and a shortage of 46,000 surgeons and medical specialists in the next decade.”

As the national statistics on shortage of physicians only provides a perspective value, little is known on how serious the maldistribution is between physicians and patients in local communities, according to Edward Salsberg, Director of National Center for Health Workforce Analysis in the U.S. Department of Health and Human Services. To address these issues, the briefing was divided into three panels with speakers presenting on setting the stage for health workforce policy in the ACA era; restructuring medical education; and new models of care/reaching vulnerable populations.

Push for Graduate Medical Education (GME) dollars towards medical training programs has been in place for years and has garnered many supporters from groups and individuals who are in favor of accelerating the physician workforce transformation. ASCP supports Graduate Medical Education in Pathology by developing and offering policies, programs and products that address the full range of resident and fellow competencies. ASCP also acknowledges the importance of research in GME, and supports it through its programs and advocacy. Payments for GME should recognize all components of costs, including residents’ stipends and benefits, salaries and benefits related to faculty supervision and allocated overhead expenses.

Restructuring the healthcare workforce, however, goes beyond efforts to unfreeze GME funding to creating new models of care. Increased utilization of nurse managed health centers and patient-centered medical homes could alleviate the impending physician shortage. Physician assistants, nurse practitioners, and pharmacists were said to be professions that are key in accountable care organizations and integrated care teams. Absent in the discussion is the role of laboratory professionals in the delivery of primary care. As the demand for health care services continue to increase, the new models of care should include the laboratory professionals in the discussion. With approximately seven to 10 billion laboratory tests performed annually, they are well qualified to provide recommendations for appropriate testing ordering, identify prevention efforts that focus on patients most likely to benefit, and report healthcare historical trends. ASCP continues to support initiatives addressing the pathology and laboratory medicine workforce and the overall healthcare workforce shortage through advocacy and research.

Both the Association of American Medical Colleges (AAMC) and Health Affairs distributed issues of their journals related to the briefing. For copies, contact both institutions directly. (Academic Medicine, December 2013 issue and Health Affairs, November 2013 issue)





Cancer Diagnostics and Personalized Medicine Symposium Address Transforming Cancer Care

The American Association for Cancer Research (AACR) and AdvaMed hosted a diagnostics symposium to discuss advances in molecular tests that will revolutionize cancer care and policy issues affecting patient access to advanced diagnostics. Francis Collins, MD, PhD, Director of National Institutes for Health; Margaret Hamburg, MD, Commissioner of the United States Food and Drug Administration; and Harold Varmus, MD, Director of the National Cancer Institute, presented talks on the state of personalized medicine. Jack Andraka, the 16-year- old winner of the Gordon E. Moore Award, who spoke at ASCP 2012 Boston, provided a speech on his new method to detect pancreatic cancer. With advances in technology going at a faster pace than before, “larger cancer gene panels driven by low costs of sequencing and increased utility of comprehensive tests is what the future looks like for genomics,” said Raju Kucherlapati, PhD, the Paul C. Cabot Professor of Genetics and Professor of Medicine at Harvard Medical School, Boston. In addition to the science behind cancer diagnostics, better methods for approval, regulations, reimbursement, and uptake is needed to ensure patient safety and innovation as well as patient access to innovative diagnostics. ASCP continues to monitor developments on this topic. The video and slides of the event are available on the AACR website.


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