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ePolicy News October 2013

Wednesday, October 2, 2013



ASCP Members Flood CMS with Letters Over PFS/CLFS Proposed Rule

ASCP members have rallied to make their voices heard in a concerted campaign to change the Centers for Medicare and Medicaid Services’ 2014 Physician Fee Schedule (PFS) and Clinical Laboratory Fee Schedule (CLFS) Proposed Rule. More than 2,200 letters made their way to the agency through the ASCP e-Advocacy Center in response to several ASCP action alerts about CMS’s proposed cap on non-facility Physician Fee Schedule (PFS) payment rates. ASCP members should feel especially proud of the fact that they sent more than 2,200 letters to CMS, out of the 10,185 comments that the agency has so far acknowledged it has received on the proposed rule. In addition, members of Congress received almost 8,000 letters as a result of ASCP’s action alert to Capitol Hill—an alert that is still actively urging members of Congress to raise concern about the plan with CMS.

In addition, ASCP and the American Pathology Foundation (APF) co-authored a comment letter to CMS, voicing strong concerns about several of the proposals housed in the Proposed Rule. ASCP and APF urged CMS to withdraw a proposal to cap non-facility technical component charges for pathology (physician) services at Medicare Hospital Outpatient Prospective Payment System (OPPS) rates. ASCP and APF also raised concern about a proposal to revalue the entire CLFS.

In their comments to the agency, ASCP and APF noted that for almost all of the 39 pathology services affected by the proposal, CMS’s own cost data shows that the proposed payment rates fail to cover the direct costs of providing these services. ASCP and APF noted that for a number of common pathology services used to identify cancer and other diseases, the proposed payment rates would be cut by 40 percent or more. ASCP and APF raised concerns that the proposal could force some labs to close or stop offering certain tests and that these results could create access to care issues for all patients—not just Medicare beneficiaries.

Additionally, ASCP and APF raised concerns about CMS’s proposal to revalue the CLFS to capture perceived efficiencies brought about by technological change. The proposal would require the agency to update payment rates for over 1,250 codes on the CLFS over a five-year period beginning next year. ASCP and APF argued that the proposed project scope is overly aggressive. The joint letter cited the current difficulties and delays around revaluing the 114 molecular pathology codes as supporting evidence that revaluing 250 codes a year may be exceedingly difficult to execute. ASCP and APF urged that if the agency intends to move forward with this proposal that it should roll back the scope of the project, work closely with stakeholders, and adopt a more transparent process—among other “asks.”

ASCP and APF also raised a number of broad concerns about several quality reporting programs, such as the Meaningful Use (MU) program and the Physician Quality Reporting System (PQRS). While these programs may have goals that are achievable for some physician specialties, the programs have proven especially difficult for some physician specialists, especially pathologists, due to the lack of relevant specialty-specific measures and/or unrealistic reporting requirements. As a result, ASCP and APF offered strong support for the five existing quality measures for pathology but expressed great disappointment that CMS did not include the three additional pathology-specific measures recommended by the College of American Pathologists. ASCP and APF urged CMS to provide increased flexibility to the system to prevent pathologists from being penalized for non-compliance when compliance may not technically be possible.

Additionally, the joint ASCP-APF letter urged CMS to reconsider its proposal not to accept some of the direct price input recommendations identified by the American Medical Association’s Resourced-based Relative Value Scale Utilization Committee (RUC) for valuing certain services, such as the surgical pathology and cell enumeration services. To obtain a copy of the ASCP/APF letter outlining these and other issues, click here.


Obamacare “Open for Business” Despite Federal Government Shutdown

Partisan disagreements over the implementation of the Affordable Care Act (ACA), commonly referred to as “Obamacare,” have fueled arguments between the House and Senate, preventing the passage of a federal spending bill for Fiscal Year 2014. As a result, Oct. 1, 2013 will go down in history for its irony, marking the first federal government shutdown in nearly 20 years on the same day that the ACA-developed health insurance marketplace is officially “open for business.”

For the past two weeks, the House and the Senate have been engaged in a game of political ping-pong. The Republican-controlled House continues to attach amendments intended to defund and deactivate the ACA, only to be rejected by the Democratic-controlled Senate and sent back to the House sans amendments. The inability of the President and Congress to agree on a federal spending bill means that previously approved federal appropriations have expired, forcing a federal government shutdown that halts all discretionary spending. However, because the ACA is largely funded with mandatory spending, open enrollment in state-level health insurance exchanges has begun on schedule.

On Oct. 1, the U.S. Department of Health and Human Services launched, a virtual one-stop shop for information regarding eligibility and enrollment in qualified health plans participating in state-level health insurance exchanges. The exchanges are intended to drive a more regulated consumer marketplace with more affordable and transparent healthcare coverage options and available federal subsidy assistance. Beginning in January 2014, consumers who have not purchased health insurance through an exchange and are unable to receive health insurance through Medicare, Medicaid, and/or their employer will face a penalty of $95 or 1 percent of income, whichever is greater. This penalty increases to $695, or 2.5 percent in 2016.


ASCP Opposes CMS Plan to Bundle Laboratory Services into OPPS

On Sept. 6, ASCP wrote to CMS in opposition to its 2014 Outpatient Prospective Payment System (OPPS) Proposed Rule. The Proposed Rule outlined CMS’s plans to package, or “bundle,” more than 1,000 clinical laboratory tests and 80 pathology services, currently paid separately, into OPPS payment rates. CMS maintains that the proposal would reduce the incentives for providing unnecessary laboratory services in the outpatient setting.

ASCP raised several objections to the CMS plan. The Society argued that the proposal is an untested expansion of existing OPPS packaging and that it has the “potential for significant adverse consequences and unintended consequences…” ASCP also faulted the proposal for lacking the detail necessary to enable appropriate, relevant review and comment from the stakeholder community. For example, ASCP stated in its letter that “it is unclear whether CMS has incorporated within the payment for the primary service bundle sufficient funds to cover currently separately paid services.” Additionally, ASCP noted that, contrary to convention, CMS did not provide an impact analysis as to how the proposal would affect pathology and laboratory medicine. Impact assessments are typically included in Medicare proposed rules and are a critical tool for gauging the scope and impact of agency initiatives. To obtain a copy of the ASCP comment letter, click here



House Bill Advocates for a Halt on Harmful Self-Referrals

On Aug. 1, 2013, Congresswoman Jackie Speier [D.-Calif.] introduced H.R. 2914, entitled “Promoting Integrity in Medicare Act of 2013 (PIMA).” In regulatory terms, PIMA advocates for what is commonly referred to as “Stark reform.” The Stark law, formally known as the Ethics in Patient Referrals Act, prohibits clinicians from making referrals to organizations with which they have a financial relationship. However, federal statute allows for certain service types to be exempt from the Stark law, based on its application of the In-Office Ancillary Services Exception (IOASE). When an IOASE applies to a service type, physicians are able to “self-refer,” or make “within practice” referrals, for these service types in lieu of referring these services to a non-affiliated laboratory or pathologist’s office. As such, passage of PIMA would eliminate anatomic pathology (AP), diagnostic imaging, radiation therapy, and physical therapy services from the list of service types for which the IOASE applies, resulting in the prohibition of self-referral of these service types.

AP services were originally categorized as “ancillary” and included under the IOASE to encourage self-referrals that result in on-site delivery of AP services during the clinician office visit. However, AP services have proven too complex for this, and now the ability of clinicians to self-refer for these services is harming patients, rather than streamlining access, as initially intended. For example, multiple studies have found that the ability to self-refer can incentivize abusive billing patterns, resulting in overutilization and increased costs for both Medicare beneficiaries and tax-payers. Worse yet, this overutilization often results in distorted rational medical decision-making and inappropriate testing that can potentially threaten patient safety.

PIMA cites many reputable studies intended to demonstrate the harmful implications of continuing to allow self-referral of AP services, absent Stark reform. For example, a 2012 Health Affairs study found that non-self-referring urologists had, on average, a 12 percentage point higher prostate cancer detection rate than self-referring providers in 2007. This suggests that financial incentive was causing urologists to perform prostate biopsies on men who are unlikely to have prostate cancer. More recently, in a September 2012 report to Congressional Requestors, the Government Accountability Office (GAO) found that in 2010, self-referring clinicians referred over 918,000 more AP services than non-self-referring clinicians. This cost Medicare approximately $69 million that year alone.

ASCP released an action alert on Oct. 1, asking members to write to their members of Congress immediately, urging them to support Stark Reform and co-sponsor PIMA. The ASCP Action Alert can be accessed in the ASCP eAdvocacy Center. Please join with us to protect our patients from these harmful self-referral practices!

For more details on this issue, please see ASCP’s Policy Statement on “Self-Referral, Markups, Fee Splitting, and Related Practices.” 


PEPFAR Bill Introduced in the Senate & House

A new bill designed to extend certain critical authorities and strengthen program oversight of the President’s Emergency Plan for AIDS Relief (PEPFAR) was introduced last month in both the U.S. Senate and the U.S. House of Representatives.

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. These provisions extend 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 to conduct cost studies of assistance to “partner countries” and expenditure analyses by partner countries. It 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.).

Senators Menendez and Corker plan to schedule a vote on the bill in committee, which could prompt amendments. The bill will, in any case, then have to pass the House and Senate, where many new members have not previously weighed in on PEPFAR.

Click here to see the letter from multiple organizations including ASCP to Congress supporting the PEPFAR Stewardship and Oversight Act of 2013. 




New ASCP Report Outlines Strategies to Address Laboratory Workforce

The demand for services from the nation’s medical laboratories is predicted to dramatically increase as our citizens age and millions receive insurance coverage through the Affordable Care Act. Building a Laboratory Workforce to Meet the Future, a new report from ASCP, provides a comprehensive strategy to address the future workforce needs of the nation’s medical laboratories to meet this demand in order to provide timely, accurate, and safe patient care and fully realize the benefits of personalized medicine. The report, from the ASCP Task Force on the Laboratory Professionals Workforce, is a comprehensive review of the myriad factors that impact recruitment and retention of qualified laboratory professionals. It provides a set of thoughtful recommendations outlining a multi-faceted approach to bolster the pipeline of potential candidates for the profession, as well as leadership in health care.

The charge of the Task Force included a review and evaluation of current laboratory professions data to identify gaps and provide recommendations for future data collection initiatives; a review of ASCP’s role in workforce development; and an examination of how ASCP might leverage its resources and standing among other pathology/laboratory medicine organizations and industry, government, and the broader healthcare system to develop and achieve long-term objectives.


CGI Update: Workforce Survey to Focus on Licensing Requirements in New York

As part of ASCP’s Commitment to Action with the Clinton Global Initiative (CGI), ASCP and the New York State Clinical Laboratory Association, Inc. (NYSCLA) are partnering to conduct a survey of the laboratories and testing personnel in New York State. The objective of the survey is to determine the impact of the law that requires the licensing of testing laboratory personnel in New York State by the State Education Department (SED) on hiring practices. The survey will determine whether there are enough personnel and educational programs available to satisfy the needs of the laboratories operating in New York and deliver data-driven information useful to the state legislature and various regulatory agencies. It will launch in October 2013, and results will be released in January 2014.

ASCP’s CGI initiative, Expanding the Laboratory Workforce for the 21st Century, is a 5-year commitment to expand the capacity of the clinical laboratory workforce in the state of New York, with implications for future similar initiatives across the nation.

Halt to Budget Cuts on Health Professions Workforce Programs Urged

The Health Professions and Nursing Coalition (HPNEC) held a briefing on Capitol Hill to mark the 50th anniversary of the Health Professions Workforce Programs. The briefing emphasized the importance of Title VII and Title VIII programs in supporting the healthcare workforce and the community. These programs are becoming even more critical as the nation’s population becomes more diverse and ages, creating an increased demand for care. However, sequestration on Title VII and Title VIII programs threatens to affect communities nationwide, impacting children, adults, and seniors; practicing health professionals and faculty; and aspiring and enrolled health professions students and trainees.

Cuts in funding of the Health Careers Opportunity Program (HCOP) and the Center of Excellence (COE), two diversity programs authorized under Title VII, will decrease diversity in the health professions and training healthcare personnel, according to a survey conducted by the Association of American Medical Colleges (AAMC). These students and trainees are vital to health care because they are “more likely to be culturally competent healthcare professionals who often go on to serve underserved communities.” The health care of older adults is also threatened by the Title VII Geriatric Health Professions budget cuts. The Eldercare Workforce Alliance indicated that “within 20 years, one in five Americans will be over 65; 90 percent of those Americans will have one or more chronic conditions.” This is the only federal program that increases the number of faculty with geriatrics expertise. Decreasing the budget would affect the future supply of geriatric professionals and deprive the elderly of appropriate care.

Over the years, the programs have continued to evolve to address the nation’s needs. Federal funding is crucial to sustain and strengthen these initiatives.




ASCP 2013 Chicago Showcases Policies that Impact Patient Care

Last month, more than 1,500 pathologists and medical laboratory professionals gathered at the Hyatt Regency Chicago for ASCP 2013 Chicago, ASCP’s annual meeting. This remarkable event featured a keynote address from a former U.S. Secretary of State to renowned leaders in health care, all of whom who urged ASCP members to take an active role in shaping the future course of pathology and laboratory medicine.

Promoting policies that support positive outcomes for patients was the focus of the general sessions as well as many educational sessions. ASCP’s participation in the landmark U.S. Supreme Court case that recently ended the 30-year practice by the U.S. Patent Office of issuing patents for human genes was showcased in Perspectives on the Supreme Court Gene Patent Ruling. Chris Hansen, Former Staff Attorney for the ACLU and lead counsel in ASCP’s challenge to the patenting of human genes, provided an overview of the legal battle and an analysis of the ruling. Myla Lai-Goldman, MD, FASCP, CEO of GeneCentric Diagnostics, discussed the impact of the ruling for the future of personalized medicine and the laboratory industry. Lee H. Hilborne, MD, MPH, FASCP, DLM (ASCP)CM, discussed ASCP’s perspective and why, as a patient-centric organization, its participation as a plaintiff in the case was imperative.

Putting Pathology and Laboratory Medicine in the Driver's Seat for Tomorrow's Health Care featured two leading pathologists at the center of the national debate on appropriate test utilization in an effort to reduce testing costs while improving patient care. Gary Procop, MD, FASCP, Chairman of the Department of Molecular Pathology at the Cleveland Clinic, Cleveland, developed a successful review process of duplicative testing, now a model for health systems nationwide that demonstrates how a large health system can save money while reducing the volume of tests performed. Elaine Jeter, MD, Medical Director of Palmetto, GBA, LLC, one of Medicare’s larger insurance carriers in Columbia, S.C., crafted a reimbursement scheme for molecular testing. Lee H. Hilborne, MD, MPH, FASCP, DLM(ASCP)CM, Medical Director for Quest Diagnostics in Southern California and Professor of Pathology and Laboratory Medicine at the University of California, Los Angeles, moderated the session. He highlighted ASCP’s participation in the Choosing Wisely campaign launched by the American Board for Internal Medicine to promote patient-physician discussions about appropriate care.


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