ePolicy News October 2016

Monday, October 3, 2016

Laboratory Community Meets with CMS on Nursing Degree Issue, Presents Petition with 35K+ Signatures

The ASCP Board of Certification (BOC), ASCP, and American Society for Clinical Laboratory Science (ASCLS) met on Sept. 27 with the Centers for Medicare and Medicaid Services (CMS) in opposition to the Agency's recent declaration that a degree in nursing is equivalent to a degree in the biological sciences. The meeting began with ASCP, ASCLS and BOC presenting CMS with a petition, signed by more than 35,000 individuals opposed to CMS's degree equivalency policy. The petition drive was a community-wide effort led by ASCP and ASCLS to raise concern about CMS's policy that the nursing degree is equivalent to a biological sciences degree for purposes of doing non-waived laboratory testing under the Clinical Laboratory Improvement Amendments (CLIA) of 1988. During the meeting, representatives of the BOC, ASCLS, and ASCP then outlined many of the key reasons why biological science and nursing degrees are not equivalent.

As ASCP's e-Policy has previously reported, the Agency's action, outlined in an April 1 memo, could allow an individual with a bachelor's degree in nursing to perform high complexity testing. Per the CLIA regulations, individuals with a bachelor's degree in a chemical, physical, or biological science are not required to complete training prior to performing high complexity laboratory testing. The April memorandum provided no reasoning behind the decision. 

During the meeting with CMS, Agency officials stated that the memorandum reflected a long standing internal policy which had been developed due to a concern about a shortage of testing personnel at physician office laboratories in rural areas. These testing sites are not often staffed by qualified laboratory professionals, such as those individuals who may be certified by the BOC. In response, representatives from ASCP, ASCLS, and the BOC raised concerns about optimum patient care and the need to ensure the accuracy and reliability of all laboratory test results, since test errors can result in unnecessary testing or serious harm to the patient.

In addition, ASCP, ASCLS, and BOC representatives discussed typical degree requirements for nursing degree programs, noting that they fall far short of the scientific coursework required to earn a degree in the biological sciences. In its June 22 letter to CMS, the BOC Board of Governors articulated concerns that nursing degrees provide only a fraction of the scientific coursework required for a biological sciences degree and that what scientific coursework nursing programs do require does not approach the level of difficulty involved in obtaining a biological sciences degree.

During the meeting, representatives cited comments received from their respective memberships, including those from several individuals who hold degrees in both nursing and the biological sciences that agreed that the nursing degree does not provide the scientific foundations necessary to perform non-waived laboratory testing reliably.

The Agency indicated that it understood and appreciated our concerns. Agency representatives also indicated that CMS will be working to address this issue and that it is currently examining how best to implement a change in policy. CMS noted that fixing this issue may require the Agency to propose new regulations and that if such a change is required it will soon begin working on draft regulations. 
Attending the meeting were ASCLS Executive Vice President Jim Flanigan, CAE; ASCLS Executive Vice President Emeritus Elissa Passiment, EdM; ASCP Chief Executive Officer E. Blair Holladay, PhD, SCT(ASCP)CM; BOC Executive Director Pat Tanabe, MPA, MLS(ASCP)CM; ASCP Chief Officer for Science, Technology and Policy Jeff Jacobs, MA; and ASCP Director for the Center for Public Policy Matthew Schulze.

ASCP and the BOC appreciate the invaluable assistance the ASCLS has provided as a partner on this issue. Together, we will be working with CMS to develop a solution and hope to report progress on newsworthy developments soon.

CMS Releases Template for New CLFS Data Reporting Requirement

On Sept. 8, the Centers for Medicare & Medicaid Services (CMS) released (and subsequently updated on Sept. 14) a user guide intended to assist the laboratory community in complying with data submission requirements included in the Protecting Access to Medicare Act of 2014 (PAMA) revaluation of the Clinical Laboratory Fee Schedule (CLFS) Final Rule.

As previously reported, beginning on Jan. 1, 2018, CMS will set payment rates based on the weighted median of private payer rates, as reported by applicable laboratories during a specified time period. To develop these new payment rates, PAMA requires applicable laboratories to report data on payment rates and test volume no later than March 31, 2017. ASCP advocated for reduced reporting burden in our response to the PAMA Proposed Rule, and in response, CMS is attempting to minimize this burden. Accordingly, the user guide and associated data reporting template will provide instructions and the required fields for submitting information to CMS.

The template file, "CLFS-Lab Data-Collection-Final.csv" can be accessed on the Clinical Laboratory Fee Schedule website in the "Downloads" section. Data can be submitted through an online interface or via comma separated value (.csv) format using a file upload process. The template can be opened using a text editor, such as Notepad or a spreadsheet application such as MS Excel. Four fields are required: (1) HCPCS Code; (2) Payment Rate; (3) Volume; and (4) National Provider Identifier. CMS is explicit that fields, columns, and headings not be changed within the template.

Relatedly, on Oct. 3, the Office of the Inspector General (OIG) released two PAMA-mandated reports detailing findings on CMS's implementation of the new payment system and its impact on Medicare payments for lab tests. OIG found that, overall, Medicare payments for lab tests have remained constant from 2014 to 2015 ($7 billion paid by Medicare Part B for lab tests in both years). Notably, Medicare payments for drug tests increased by 19 percent, and payments for molecular pathology tests decreased by 44 percent. OIG also found that CMS has made significant progress in implementing the new payment system as they have completed most or all critical implementation tasks with plans to complete the remainder before the Jan. 1, 2018, effective date. Nonetheless, OIG notes concern over two aspects of the new system and its implementation: (1) although CMS requires certain labs to report data, it does not plan to verify whether they do so; and (2) CMS does not plan to independently verify the completeness or accuracy of the data that is reported.

ASCP will continue to monitor any developments related to PAMA compliance/implementation and provide information on how the laboratory community can meet the new requirements.

ASCP Participates in Successful Pink Ribbon Red Ribbon Hill Day

As a collaborating partner in the Pink Ribbon Red Ribbon (PRRR) organization, ASCP took to Capitol Hill on Sept. 28 to help PRRR celebrate its fifth anniversary and spread the word about the critical work the organization does in reducing the number of unnecessary deaths from cervical and breast cancer in less-developed regions. For the past five years, PRRR has worked with national governments, non-governmental and multilateral organizations, the private sector, and key in-country leadership to prevent and treat cervical cancer, and provide early detection and treatment of breast cancer.

As one example of ASCP's involvement and collaboration activities, ASCP recently worked with PRRR to clear a massive backlog of cytology slides that had piled up due to broken equipment and lack of trained laboratory staff in Botswana's National Health Laboratory. ASCP volunteers read almost 3,600 slides to provide women in Botswana with their cancer status. Additionally, ASCP followed up by training a cadre of laboratory professionals, and ensured that equipment was upgraded and properly maintained.

Along with PRRR staff and other partner organizations, ASCP met with members of Congress to build awareness and develop relationships in support of the long-term pursuit of U.S. policies that promote women's health and support PRRR activities. 

Zika Funding Finally Passes

On Sept. 28, Congress passed a Continuing Resolution (CR) that contains long-awaited Zika funding. The legislation, which includes $1.1 billion in funding for the federal Zika response, was signed into law the next day. Over the last several months, ASCP has worked closely with the March of Dimes strongly urging Congress to provide resources to combat the spread of the Zika virus. ASCP has supported the March of Dimes' tireless efforts including several sign-on letters, innumerable social media posts, and hundreds of Hill meetings. We are very pleased that this funding has finally passed as it has been a hard-fought victory for mothers, infants and families across the globe. The White House issued a statement supporting the CR agreement. Additionally, a summary of the CR and Zika provisions released by Congresswoman Lowey (D-NY) can be found here.

ASCP Briefs Laboratory Community on Draft Guidelines at Annual Meeting

The 2016 ASCP Annual Meeting in Las Vegas featured two sessions on Sept. 16 related to our organization's commitment to clinical practice guideline development.  Our first guideline session was on the ASCP/CAP/AMP/ASCO Molecular Testing Guideline for the Selection of Colorectal Cancer Patients for Targeted and Conventional Therapies. This session featured ASCP guideline Chair Wayne Grody, MD, PhD, UCLA Medical Center, and AMP Chair Antonia Sepulveda, MD, PhD, Columbia University, who walked the audience through the 21 recommendations (draft at present) contained in the supporting manuscript—now in final publication review. 

This lengthy guideline was the result of collaboration among four organizations, with ASCP in the lead, along with AMP (Chair Dr. Sepulveda), CAP (Chair Dr. Stanley Hamilton), and ASCO (Chair Dr. Carmen Allegra). "By bringing together four key organizations, all with substantial interest in treatment of colorectal cancer, we have addressed multiple elements of the patient care continuum," said Dr. Grody. Dr. Grody and Dr. Sepulveda also participated in a video interview session to be released as part of the dissemination process upon guideline release.

The second guideline session addressed the CAP/ASCP/ASCO Joint Guideline on HER2 Testing in Gastroesophageal Adenocarcinoma, featuring two faculty members: ASCP guideline Chair Dr. Kay Washington, MD, Vanderbilt, and ASCO Chair Dr. Jaffer Ajani, MD, an oncologist from MD Anderson Cancer Center. The CAP guideline Chair and lead is Dr. Angela Bartley. Thoughtful questions were fielded from the audience for both sessions, as participants took advantage of the opportunity to speak to faculty main authors. Final publication of both of these guidelines is expected in November 2016. ASCP's ePolicy will update readers on how to access the guidance documents once they are published. 

Fda Briefs Medical Societies On Pmi And Oversight Of Next-Gen Sequencing

The role and responsibilities of the Food and Drug Administration (FDA) in the implementation of the Precision Medicine Initiative (PMI) was the focus of a Sept. 14 discussion. This discussion, which included representatives from various physician specialty organizations, was an opportunity to hear about the FDA's plan for regulation of Next-Generation Sequencing (NGS). Dr. Katie Johansen Taber, Director of the AMA Personalized Medicine Program, expressed the AMA's interest in PMI and its effects on physician practice; particularly how physicians can play a role in the way PMI will be implemented to assist patient care.

Dr. David Litwick, of the Office of Personalized Medicine, spoke extensively on the two draft guidances released in July of this year. Dr. Litwick stressed the collaborative nature of the PMI and stated that FDA is looking for input and discussion from the community, namely in identifying areas where "we can work together and make something that will benefit everybody." Dr. Litwick explained that PMI is not just about research but also about helping to get new and better tests, innovation, and technology to patients in a way that is safe and effective.

Due to the potential for NGS to identify millions of variants within individual patients, it is important to determine what these variants mean and how their identification will affect patient care. FDA would like to regulate PMI in a manner that ensures accuracy and reliability of NGS tests while simultaneously encouraging innovation. They hope to do so by creating a system of standards, databases, and policies that would accommodate the rapid evolution of this technology.  Dr. Litwick explained how the first draft guidance presents a number of simple technical and regulatory recommendations centered on how to design a NGS test in a way that would meet FDA regulations pertaining to analytical validity in a manner that provides an efficient path to market—potentially without premarket review. Dr. Litwick noted that the final list of recommendations has yet to be determined, but that this would be done with the collaboration of the community, ideally with the community creating the standards. The second draft guidance is focused on genetic databases to support the clinical variables produced from these tests. The FDA hopes to aggregate information from various sources on genetic variants to provide a stronger evidence base for clinical validation of test results. The benefits of this proposed plan would be to increase efficiency for test developers and the FDA, to provide a more dynamic way of leveraging information and the latest scientific knowledge as well as to create more transparency.

When asked whether Laboratory Developed Tests (LDTs) would fall under the regulations of the FDA guidances, if finalized, Dr. Elizabeth Mansfield, Director of the Office of Personalized Medicine, responded that the guidances cover NGS and do not define or regulate anything that FDA has not regulated in the past. However, she did acknowledge that many NGS tests are currently LDTs and so the best practices approach FDA is putting forth could have application.  Dr. Litwick echoed this by explaining that standards would be created by the community and if they are truly the best practices than many people will voluntarily conform no matter where they fall in terms of regulation.

Senate Committee Hearing Reveals Continued Disagreement Over LDT Oversight

On Sept. 20, the Senate Committee on Health, Education, Labor, and Pensions held a hearing on the regulation of laboratory developed tests (LDTs). The hearing, which involved testimony from two pathologists, a representative from a diagnostic device manufacturer and a representative from a cancer-focused policy organization organization, provided ample evidence that seeking agreement on the appropriate level of regulation for LDTs is an elusive task. Disagreement exists not only on the appropriate level of oversight but also which federal agency—The Food and Drug Administration or the Centers for Medicare and Medicaid Services—should regulate LDTs. The witnesses testifying before the committee agreed that whatever regulatory framework is established must ensure patient access to necessary laboratory testing and that these tests must be safe and effective. That said, concerns continue regarding the scope and cost of regulatory oversight and what impact it might have on patient access to testing.

Notably, Republican congressmen on the Committee argued that FDA regulation would be overly burdensome to keep up with innovation in the molecular diagnostics space in particular. Committee Chairman Lamar Alexander (R-TN) especially worried that FDA approval would limit patients' ability to receive critical tests, and would be financially unsustainable for many labs.

Testifying before the Senate Committee were David S. Klimstra, MD, Attending Pathologist and Chairman, Department of Pathology, James Ewing Alumni Chair In Pathology, Memorial Sloan Kettering Cancer Center, Professor of Pathology and Laboratory Medicine, Weill Medical College of Cornell University; Brad Spring, Vice President, Regulatory Affairs and Compliance, BD Life Sciences, Baltimore, MD; Jeff Allen, PhD, President and CEO, Friends of Cancer Research, Washington, DC; Karen L. Kaul, MD, PhD, Chair, Department of Pathology and Laboratory Medicine, Duckworth Family Chair, NorthShore University Health System, Clinical Professor of Pathology, University of Chicago Pritzker School of Medicine, Evanston, IL.


For more information regarding ASCP's advocacy initiatives and policy positions, please contact ASCP's Center for Public Policy at (202-347-4450).


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