ePolicy News April 2017

Apr 27, 2017
Read the latest ASCP policy news from Washington, DC.

CMS Responds to ASCP’s Concerns – Extends PAMA Reporting Deadline

On March 30, one day before the reporting window was to close, the Centers for Medicare and Medicaid Services (CMS) responded to ASCP’s request to give applicable laboratories more time to report their private payor pricing data. CMS has agreed to “exercise enforcement discretion” for 60 days, thereby extending the reporting deadline required under the Protecting Access to Medicare Act (PAMA) to May 30, 2017. Applicable laboratories had until March 31 to report, but after receiving feedback that labs were having difficulty compiling the required data and using CMS’ data reporting system, CMS agreed to push back the deadline.

Recall that PAMA requires CMS to replace current Medicare Clinical Laboratory Fee Schedule (CLFS) payment rates, which are based on historical lab charges adjusted for inflation, with new rates based on current charges in the private insurance market. CMS issued a final rule on implementing the law last year. At the urging of ASCP and others in the laboratory community, it agreed to push the implementation date to Jan. 1, 2018.

While we appreciate the extension, ASCP recently signed on to a letter urging CMS to delay PAMA implementation by one year as we remain concerned by the way the Agency has defined “applicable laboratories.” ASCP maintains that the definition fails to capture the entire laboratory market. According to a report from the Office of the Inspector General, around half of the more than 3,200 independent laboratories, a small portion of physician laboratories, and a few hospital outreach laboratories that obtain a National Provider Identifier will be required to submit data. As such, new payment rates will reflect pricing data provided by just 5 percent of laboratories, which account for 69 percent of Medicare payments in 2015. ASCP is concerned that the new payment rates, which will be heavily influenced by laboratories with significant economies of scale, may not be sustainable for smaller independent and hospital outreach labs.

While ASCP supports reform to the current Medicare CLFS payment system, the new system must not hinder patient access and must recognize the importance of diagnostic medicine in the overall healthcare scheme. ASCP will continue to monitor and report on developments in PAMA implementation as they occur.

ASCP Endorses LCD Reform Bill

ASCP is supporting legislation introduced by Senator Johnny Isakson (R-GA) to reform the Medicare Local Coverage Determination (LCDs) Process. The bill, called the Local Coverage Determination Clarification Act of 2017 (S. 794), is being championed by the College of American Pathologists.  The bill would increase the level of transparency and accountability placed on Medicare Administrative Contractors (MACs) in developing LCDs. The bipartisan measure, co-sponsored by Senators John Boozman (R-AR), Thomas R. Carper (D- DE) and Debbie Stabenow (D-MI), would revise the process by which MACs issue and reconsider LCDs. MACs are private insurers that process Medicare claims within specified geographic areas.

The bill would require MACs to do the following when developing LCDs: (1)  publish online a proposed version of the determination and other specified, related information; (2) convene one or more public meetings to review the draft determination, receive comments, and secure the advice of an expert panel; (3) post online a record of the minutes from each such meeting; (4) provide a period for submission of written public comments; and (5) post online specified information related to the rationale for the final determination. The measure also outlines procedural requirements MACs must follow when a request for a reconsideration of a LCD by an interested party and would establish an ombudsman and appeals process within CMS to support the LCD process. ASCP will be working with Senator Isakson and the College of American Pathologists to advance the measure.

ASCP Disagrees With CMS Nursing Policy

The Centers for Medicare and Medicaid Services formally responded on March 13 to a letter from ASCP, the ASCP Board of Certification (BOC), and the American Society for Clinical Laboratory Science (ASCLS). CMS was responding to a letter, detailed in last month’s ePolicy. ASCP, BOC and ASCLS wrote CMS, urging the Agency to respond in writing that the biological sciences do NOT include nursing. Unfortunately, CMS still is holding fast to its April 1, 2016 announcement that a bachelor’s degree in nursing is equivalent to a degree in biological sciences. Per CLIA, this means that an individual with a bachelor’s degree in nursing can perform high complexity testing and that they do not need to satisfy any clinical training requirement before doing so. It also means that an individual with a nursing degree can qualify to direct a moderate complexity lab or serve as the supervisor of a high complexity laboratory.

ASCP disagrees with CMS’ position that a rule is necessary to change the Agency’s policy. ASCP is concerned that a rule change could take years to accomplish and that to protect patient health urgent and timely action is needed to fix this policy.

ASCP, BOC, ASCLS Urge Changes to Laboratory De-Licensure Legislation in Florida

On March 30, ASCP and the ASCP Board of Certification (BOC) teamed up with the American Society for Clinical Laboratory Science (ASCLS) to raise concern about legislation under consideration in the Florida legislature that would end the state’s licensure of clinical laboratories. But in the process of eliminating laboratory licensure, the legislation, apparently accidentally, would also eliminate the Board of Clinical Laboratory Personnel (BCLP). This could have dire consequences for the state’s licensure of clinical laboratory personnel.

In responding to the issue, ASCP reached out to State Representative Alexandra Miller and Frank White, authors of H1195, the legislation under consideration in the Florida House of Representatives as well as Senator Denise Grimsley, author of SB1760, the Senate companion bill. ASCP raised several concerns with the bills besides their impact on the BCLP, including the elimination of the requirement that laboratories use licensed laboratory personnel, as well as a state law protecting patients from fee-splitting, mark-ups, and other potentially abusive billing practices involving pathology and laboratory services.

Shortly after writing these state legislators, ASCP was contacted by a representative for the Florida Agency for Health Care Administration who indicated that the elimination of the BCLP was a “drafting error” and that the Agency was working with the legislature to fix the issue. The representative also indicated that state laws to prevent patients from being adversely affected by abusive billing practices will be maintained.

For a copy of ASCP’s letter, click here.

LDT Oversight Still on Congressional Agenda

A draft bill, known as the Diagnostic Accuracy and Innovation Act, is being circulated in Congress. Introduced by Representatives Larry Bucshon, MD (R-IN) and Diana DeGette (D-CO), the legislation would call for Laboratory Developed Tests to be approved by the Food and Drug Administration (FDA). In vitro diagnostics are already under the purview of the FDA.

The draft measure would create a new, unique regulatory structure within FDA to handle the oversight and approval of “In vitro clinical tests (IVCTs).” The legislation clarifies oversight of IVCTs by clearly establishing FDA’s jurisdiction over test development and manufacturing activities while maintaining oversight of laboratory operations under the Centers for Medicare and Medicaid Services (CMS) pursuant to an updated Clinical Laboratory Improvement Amendments (CLIA) framework.

Through strong bipartisan support in Congress and across various administrations, PEPFAR has expanded its impact, strengthened partnerships, and come a long way in fighting the HIV/AIDS pandemic. Since 2005, ASCP has worked with PEPFAR funding to improve laboratory infrastructure, technology, and training in Africa and other resource-limited countries. Laboratory programs in developing countries play a pivotal role in effective implementation of prevention, care, and treatment programs.

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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