The Return of The ChAMPion!

Dear AMP members,

We are excited to announce the revival of the AMP policy newsletter, the ChAMPion, where our aim is to provide members with valuable and informative updates on public policy issues affecting molecular pathology. The AMP advocacy program is shaped by the Professional Relations (PRC) and Economic Affairs Committees (EAC). Since AMP’s founding, we have invested resources to educate policymakers and influence public policy for the good of patients and our profession by actively engaging with federal agencies and Congress regarding issues affecting our patients and our labs. In 2019, we aim to better inform the membership on these rapidly evolving issues by bringing back the ChAMPion, a newsletter devoted solely to advocacy issues. We hope that the information in the ChAMPion will encourage you to join in these conversations and continue to bring your voice to issues that affect your laboratory. Over the last several years, AMP has increased its advocacy presence in response to an increase in regulatory and legislative forces that adversely affect molecular diagnostic testing. Both committees work diligently on behalf of AMP, and our advocacy efforts are most effective and successful when the entire membership gets involved. There may be times when we request your participation and in anticipation of that, thank you in advance, and we look forward to working with and for you!

Sincerely,

Capitol Hill

AMP Expresses Concern Regarding Proposed Legislation for Laboratory Tests

In response to the Food and Drug Administration’s (FDA) 2010 announcement that it was reconsidering its policy of enforcement discretion for laboratory testing procedures (LDPs) AMP launched an aggressive campaign aimed at both the Agency and Congress. When the Agency issued a draft guidance in 2014, active engagement included successfully advocating for appropriations report language instructing the FDA to cease working on the guidance and instead, work with Congress in a transparent manner to determine the appropriate approach to oversight. In 2016, the FDA stated that they would not finalize the draft guidance regulating laboratory developed testing procedures (LDPs) and conversations regarding oversight of LDPs shifted to Congress.  Over the last few years, Representatives Larry Bucshon (R-IL) and Diana DeGette (D-CO) have been working to develop legislation to create a new regulatory paradigm for laboratory tests at the FDA. AMP remains highly engaged with Congressional offices on this issue and has provided comments on each discussion draft released by the sponsors. (You can read about the various drafts of these legislative approaches and AMP’s response to each draft here.) AMP continues to advocate that the best and most cost-effective way to improve the regulation of LDPs is to modernize CLIA via a proposal developed within a PRC working group. 

Most recently, Reps. Bucshon and DeGette released the draft Verifying Accurate Leading-edge IVCT (In Vitro Clinical Test) Development Act of 2018 (VALID Act). The VALID Act draft creates a single regulatory pathway at the FDA for both LDPs and in vitro diagnostic tests (IVDs). The framework as written would exempt low risk tests from FDA premarket review, requires premarket review for what the co-sponsors consider to be high risk test, and also proposes a voluntary precertification program for laboratories offering tests in a middle category that would allow those tests to be exempt from review if certain conditions were met. Laboratories would also have to comply with many other requirements including notification, quality system requirements, and adverse event reporting.  

On February 13, 2019, AMP submitted detailed comments on the VALID Act draft and expressed numerous concerns about the draft legislation. AMP reiterated that LDPs and IVDs are fundamentally different activities and a single regulatory system could never address their unique characteristics. Additionally, AMP stated that FDA is not the appropriate agency to regulate LDPs as AMP members provide a medical service to their patients; they are not manufacturers. AMP expressed concern that CMS was not consulted on the drafting or the language, especially because there are numerous areas of overlap between VALID Act and CLIA requirements. AMP is concerned that any confusion or overlap will place onerous administrative and financial requirements on our members and will adversely affect their laboratories. AMP also expressed concern regarding the uncertainty of and sought clarity on the two-tier risk category system, the proposed precertification scheme, how modifications to tests would be handled, and grandfathering of tests currently on the market.

AMP has learned that the lead sponsors of this draft bill plan to spend the spring and summer reviewing stakeholder comments and preparing a new draft for review. AMP continues to meet actively with members of Congress, including the co-sponsors, and maintain our seat at the table to advocate for the development of a modern and flexible oversight system that allows our members to continue providing personalized care for their patients.

Centers for Medicare and Medicaid Services (CMS)

AMP Advocates for Coverage of Hereditary NGS-based Cancer Testing in Early Stage Cancer Patients

The Centers for Medicare and Medicaid Services (CMS) provide coverage for diagnostic procedures under two different pathways: Local Coverage Determinations (LCDs) and National Coverage Determinations (NCDs). LCDs are developed by the local Medicare Administrative Contractors (MACs) for their jurisdictions, while NCDs are determined by central CMS and apply nationally. Last year, CMS released the final NCD for Next-Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer (referred to here as the NGS NCD).

AMP has been closely following the implementation of the NGS NCD. Late last year, when CMS published implementation guidance to the MACs, stakeholders discovered that CMS includes germline testing within the scope of the NGS NCD.  The implication of this interpretation is both germline and somatic tumor NGS-based testing will become non-covered for Medicare beneficiaries with early-stage cancer. In response to this, AMP spearheaded a stakeholder sign-on letter with 62 other organizations to urge CMS to revise its current interpretation of the NCD by limiting it to somatic tumor testing and to communicate this change to the MACs. This sign-on letter is significant in that it shows the diversity of stakeholders, which included providers, patient advocates, diagnostic test manufacturers, academic medical centers and laboratories, who are concerned about the downstream effects of the agency’s NGS NCD interpretation on patient care.

In response to stakeholder concern, on March 26th, the CMS Coverage and Analysis Group (CAG) announced their plans to reopen the NCD. CMS plans to do this in one of two ways, either broadly by opening the entire NCD for reconsideration, or narrowly by addressing only one or more specific aspects of the NCD. Whichever path is taken, AMP is hopeful that the result of this process will be evolution of the NCD to more accurately reflect appropriate use of NGS-based methodologies. CMS plans to reopen the NCD soon and will provide stakeholders with a 30-day comment period. AMP met with CAG on April 2 and provided recommendations on the scope of the NCD’s reconsideration.

The AMP EAC will keep members apprised of these developments. Since the announcement of the proposed NGS NCD in December of 2017, AMP members have risen to the challenge of providing expert input to CMS.  When the NCD is reopened, we will encourage our fellow AMP members to again take the time to submit comments to CMS. We also encourage AMP members to educate your colleagues and contacts who will be impacted by the NCD and take the extra time to communicate this issue within your institution (clinician colleagues, administrators, government affairs, other organizations) and work with them to submit comments. We will provide you with the resources you need to submit comments-- the more professionals, institutions, etc. that CMS hears from during the comment period, the more likely we will see a positive outcome.

New Draft Local Coverage Determinations from Palmetto GBA

Comments due June 20, 2019

At the end of March, Palmetto GBA, the Medicare Administrative Contractor that runs the MolDx program, released a number of draft Local Coverage Determinations (LCDs) that impact the coverage of molecular tests. The other MolDx jurisdictions will be releasing these draft LCDs for comment in the near future.  Three that are of particular interest to many AMP members are: MOLDX: Next-Generation Sequencing for Solid Tumors (DL38045),  MOLDX: Next-Generation Sequencing Lab-Developed Tests for Myeloid Malignancies and Suspected Myeloid Malignancies (DL38047), and MOLDX: Guardant360® Plasma-Based Comprehensive Genomic Profiling in Solid Tumors (DL38043). AMP plans to comment on these policies and encourages AMP members from MolDX jurisdictions (American Samoa, AK, AL, AZ, CA, GA, Guam, HI, IA, ID, IN, KS, KY, MI, MO, MT, NC, ND, NE, North Mariana Islands, NV, OH, OR, SC, SD, TN, UT, VA, WA, WV, and WY) to submit individual comments as well. Comments can be submitted to MolDX@palmettogba.com. If you are interested in submitting comments or want to work with AMP to develop a response, please contact the policy team at policy@amp.org for help.

AMP Expresses Concern Regarding Changes to CMS' Coding Policies

Late last year, the National Correct Coding Initiative (NCCI) contractors and the Centers for Medicare and Medicaid Services (CMS) released revisions to the Pathology/Laboratory Services section of the NCCI Policy Manual for Medicare Services, and corresponding updates to the Policy Manual for Medicaid Services, that took effect on January 1, 2019. AMP is very concerned about the effect these revisions will have on our members and the negative impact to patient access to medically appropriate molecular testing. AMP requested that the updates be withdrawn and that any future manual updates be developed in consultation with the relevant stakeholders. Additionally, AMP signed on to a letter with eight other organizations. This letter expressed concern at the process by which these updates were promulgated, requested the NCCI contractors/CMS withdraw these updates and to work with the stakeholders moving forward. In addition to these comment letters, AMP and the aligned stakeholders plan to meet and work with CMS on this issue. AMP will continue to keep you updated on this issue as conversations develop.

CMS Annual Pricing Excercise, Attn: PLA Holders

The payment rates for new and reconsidered codes on the Clinical Laboratory Fee Schedule are established through an annual process, which includes a Public Meeting and subsequent meeting with the Medicare Advisory Panel on Clinical Laboratory Tests (the Panel). The Annual Public Meeting has been scheduled for Monday, June 24, 2019 and allows interested parties to present their pricing recommendations and rationale for new codes. A month later on July 22-23, 2019, the Panel will review stakeholder recommendations and provide recommendations to CMS. Stakeholders who presented recommendations in June are encouraged to also attend this meeting too as the Panel may want to ask questions or discuss recommendations.

Please note that if you applied for and obtained a Proprietary Analysis Code (PLA code) that was released to the AMA website since August 2018, your PLA code will need to be priced by CMS this summer. CMS will release the list of codes that will be up for consideration soon. AMP will keep you updated by providing information on this process. AMP also plans to submit recommendations to CMS for new and reconsidered codes.

Registration for the Annual Meeting can be found here.

Webcast or in-person registration for the Advisory Panel meeting can be found here.

PAMA – Are You Required to Report?

Under the Protecting Access to Medicare Act of 2014 (PAMA), laboratories that perform clinical diagnostic laboratory tests are required to report the amounts that are paid by private insurers for the laboratory tests to the Centers for Medicare and Medicaid Services (CMS). CMS then sets the Medicare payment rates for laboratory tests paid under the Clinical Laboratory Fee Schedule (CLFS) based on the weighted median of the private payer data. During the CY 2019 Physician Fee Schedule rulemaking process, CMS revised the definition of “Applicable Laboratory” to now include outreach hospital laboratories.  To learn more about the updated PAMA requirements and to determine if your laboratory is an “applicable laboratory,” please refer to AMP’s December 2018 webinar. Further information on PAMA data reporting and collection, please see the CMS website here.

The next round of collecting private payor data began on January 1, 2019 and will need to be reported to CMS starting on January 1, 2020. Data must be reported by March 31, 2020. CMS will post preliminary CY2021 Medicare CLFS rates (based on the weighted median private payor rates) in late 2020 and those rates will be effective on January 1, 2021. AMP will keep members up to date on PAMA data collection and reporting deadlines.