Winter 2019

Dear AMP members,

Throughout my years of volunteering for AMP, I have been to the Hill a number of times to discuss a diverse array of issues. Most recently, I attended a day of meetings on the Hill along with a number of my colleagues during AMP’s Advocacy Day as part of AMP’s Annual Meeting & Expo in Baltimore (read more below). Since many of us spend most of our time in a laboratory and not at the bedside, it is important that our elected representatives understand how we take care of patients every day.  We need to discuss the vital role we play in patient care and the issues that we currently face in our practice.  Advocacy Day was another wonderful and important experience. In particular, my favorite part of the day was all the pictures everyone, from first timers to seasoned pros, shared of their experiences on the Hill to the AMP Advocacy Day group on WhatsApp as they met with Hill staff to discuss VALID, gene patents, and other relevant topics for AMP.  As a part of visiting the Hill, I, as well as others, invited our representatives to come and visit our laboratories, so our advocacy will continue after this one-day event. 

The reach of AMP’s advocacy work is incredibly expansive and touches on many parts of our practice. As President, I signed numerous comment letters to federal agencies and Capitol Hill on a variety of topics. During this past year, AMP achieved a number of remarkable feats, including holding AMP’s first Molecular Pathology Economics summit, leading an advocacy campaign in response to the reconsideration of the National Coverage Decision for NGS, and much more. 

While AMP has accomplished so much over this year, we know there are many new challenges and opportunities facing our profession in the future. As Dr. Karen Weck takes over as AMP President, I look forward to AMP continuing to advocate for positive regulatory policies for laboratory tests, working to improve coverage and reimbursement for molecular testing, and ensuring that the positive results of AMP vs. Myriad are not undone. It is important that AMP remains vigilant and active to ensure that our patients have access to appropriate molecular pathology tests.

While my time as AMP President has come to a close, I look forward to continuing to advocate for our profession and our patients.

Sincerely,

Victoria M. Pratt, PhD FACMG   

AMP Convenes Diverse Group of Stakeholders to Discuss the Economics of Molecular Diagnostic Testing

On September 20^th, 2019, the AMP Economic Affairs Committee (EAC) undertook a significant initiative to convene a diverse group of non-payer stakeholders from across the molecular diagnostics spectrum for a summit to identify issues and opportunities for improving the economic landscape. The event was planned by an EAC Subcommittee that included: Dr. Samuel Caughron, Dr. Pranil Chandra, Dr. Jennifer Dien Bard, Dr. Susan Hsiao, and Dr. Anthony Sireci. During the event, Dr. Amy Miller (Summit facilitator and Executive Director of the Society for Women’s Health Research) led approximately 70 representatives from the pharmaceutical industry, clinical laboratories, in vitro diagnostic manufacturing industry, patient advocacy groups, and other professional societies through a discussion around the economic issues that limit their ability to ensure patients receive the full benefit of molecular testing during their care.

In general, participants identified six major barriers:

1. Need for a better infrastructure to support innovative and robust diagnostic environment;
2. Inconsistency in clinical guidelines and “clinical utility”;
3. Lack of harmonized data approach;
4. Need to define quality across stakeholder groups and implementing quality systems across a variety of settings;
5. Need for education of patients, providers, hospitals and payers; and,
6. Maintaining and improving training of pathologists.

The event was very well received by the participants and AMP plans to continue the discussion by releasing a summary of the meeting, working to address identified barriers and solutions by attendees at the Summit, and planning to make this an annual event moving forward. AMP thanks the wonderful planning committee, the Industry Partners and the Corporate Advisory Council for their support of this successful inaugural event!

AMP Members Build Connections with Patient Advocacy Organizations

In 2016, AMP realized that due to the nature of our members’ work, which is primarily performed in laboratory facilities, most patients are unaware that they have a molecular professional on their medical team. To begin remedying this, and to build meaningful connections with patient advocacy organizations, the AMP Professional Relations Committee (PRC) launched the “Lunch and Learn” event series. The Lunch and Learns are organized by the PRC Patient Engagement Subcommittee and provide an opportunity for patient organizations and molecular professionals to have an open discussion on various aspects of molecular testing and the policies impacting the field.

During the most recent Lunch and Learn at the 2019 AMP Annual Meeting & Expo, representatives from a variety of patient organizations discussed the development of patient-facing educational materials to explain the role of molecular professionals in patient care and to help answer technical questions about molecular diagnostic testing procedures. The AMP Patient Engagement Subcommittee will continue to prepare these materials throughout the next year and plans to make them public in 2020.

This year’s Annual Meeting & Expo also included a special presentation by two patient advocacy organizations that AMP has worked closely with on a variety of issues over the last few years. Nikki Martin from LUNGevity and Lisa Schlager from Facing Our Risk of Cancer Empowered (FORCE) discussed how confusion over the terminology involved in genetic testing (e.g., somatic versus germline testing) affects patients’ comprehension of their condition. They also provided a report on current efforts by a coalition of patient and provider organizations, including AMP, to comprise a short-list of terms that all groups will agree to use in their educational materials going forward. AMP looks forward to continuing to support this effort and to continue to include the patient perspective at our annual meetings.

AMP Members Visit 100+ Legislative Offices During Recent Advocacy Day

On Tuesday, November 5th before the 2019 AMP Annual Meeting & Expo, approximately 60 AMP members ventured from Baltimore to meet with their elected representatives on Capitol Hill. This was the second AMP Advocacy Day in AMP’s 25-year history, with the first taking place five years ago as part of AMP’s 2014 Annual Meeting & Expo in Washington, D.C.

Over the course of the day, AMP members met with over 100 offices covering 26 states, to share stories of practicing molecular pathology with members of Congress and staff and to explain how several pieces of proposed legislation would affect their practice and the health of their patients. Advocacy Day participants expressed concern with draft legislation that would allow patents on genetic material as well as draft legislation that would create a new regulatory paradigm for laboratory developed testing procedures (LDPs) at the FDA. Additionally, they advocated in support of proposed legislation that would help ameliorate the effects of PAMA. AMP staff and consultants thank the participants for taking time out of their busy schedules to advocate!

You can view more photos from Advocacy Day 2019 here. 

Medicare Coverage News

AMP Urges CMS to Adopt Positive Coverage Policies for Germline NGS-based Tests

Last year, CMS finalized a National Coverage Determination (NCD) for Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer (referred to here as the NGS NCD). While the NGS NCD was intended to focus on somatic testing, AMP and other stakeholders learned late last year that CMS included germline testing within the scope of the NGS NCD. You can read further about AMP’s advocacy efforts to urge CMS to revise its current interpretation of the NCD by limiting it to somatic tumor testing here and AMP’s response to the subsequent reconsideration here.

At the end of October 2019, CMS published their proposed decision memo for the NGS NCD. In general, the proposed decision memo has three major implications for germline NGS testing for cancer patients. First, the NCD grants national coverage for FDA-cleared or –approved NGS germline tests for hereditary breast and ovarian cancer patients. However, as most of you know, the only FDA-approved germline test for breast and ovarian cancer patients utilize Sanger sequencing and there are currently no NGS germline tests that have been reviewed by the FDA. Second, the NCD grants Medicare Administrative Contractor (MAC) discretion for coverage of germline NGS-based tests (FDA reviewed or not) for any cancer (stage agnostic) other than breast and ovarian cancer. AMP has always advocated that MACs should be given discretion to design coverage policies for germline NGS-based tests; however, we are gravely concerned that MACs are not able to design coverage policies for breast and ovarian cancer patients as well. Finally, the NCD restricts coverage to one NGS test per lifetime. The full implications of this language is unclear but it appears that a patient who has previously had a somatic NGS test could be denied a germline NGS-based test.

In November, AMP submitted comments to CMS that requested the final NCD allow MACs to retain discretion to cover germline NGS tests for breast and ovarian cancer patients in order to maintain the local coverage pathway and prevent gaps in care. Additionally, AMP requested many points of clarification regarding staging, patient criteria redundancy, and repeat testing. AMP also expressed continuing concerns with the “non-coverage provision” that was added to the NCD which outlines parameters for tests that are nationally non-covered and CMS’s strategy of providing coverage policies based on NGS (a technology) instead of testing for specific biomarkers.

Stakeholders are aligned on this issue and AMP worked closely with many organizations during this comment period. Many diverse organizations shared AMP’s concerns, including provider and patient organizations. In addition to AMP’s individual comments, AMP signed on in support of The Cancer Leadership Council’s comments. AMP in conjunction with the American Clinical Laboratory Association (ACLA), assisted patient advocacy organizations with a sign-on letter in order for those who have concerns about the NGS NCD to weigh in. 

CMS Chooses Not to Finalize Changes to Date of Service Exception in Response to Stakeholder Concern

Currently, laboratories performing advanced diagnostic laboratory tests (ADLTs) and molecular pathology tests are excluded from the Outpatient Prospective Payment Systems (OPPS) packaging policy and are able to bill Medicare directly for these tests, instead of being required to seek payment from the hospital outpatient department. In the CY 2020 OPPS proposed rule, CMS sought public comments on potential changes to the laboratory date of service (DOS) exception.

AMP expressed concern to CMS about how these proposals would add additional regulatory burdens for providers and hospitals, and advised CMS to not make changes that would have a negative impact on access to timely molecular pathology testing. CMS’ proposed policy would have required ordering physicians to indicate at the time of order if the result would guide treatment during an outpatient encounter, either the current encounter or a future encounter. AMP explained that the ability of the ordering physician to predict if the test result will guide the current and any future outpatient encounters will vary widely based on the physician and the care team and stressed this suggestion was unworkable as proposed. Additionally, CMS was considering limiting the DOS exception to ADLTs. AMP strongly opposed this change and noted that CMS should not distinguish between ADLTs and molecular tests, as ADLTs are simply a type of molecular testing.

In early November, CMS released the OPPS final rule and responded to the comments of AMP and other stakeholders. Specifically, CMS agreed with the commenters that requiring an ordering physician to determine if the test result would guide treatment during an outpatient encounter, either current or future, would likely lead to delayed test ordering that would affect beneficiary access, and therefore decided to not finalize the suggested change. Additionally, CMS agreed that limiting the DOS exemption to ADLTs could lead to a delay in test ordering and will also not finalize this change.

AMP Releases Best Practices Statement for Pharmacogenomic Testing

AMP members have long recognized that clinical pharmacogenomic tests are valuable tools that can help healthcare providers determine the optimal medication or treatment for a specific patient. In September, an expert workgroup within the AMP Professional Relations Committee (PRC) authored a Best Practices Statement for Pharmacogenomic Testing. The statement includes a list of criteria for laboratories to follow for these types of tests to ensure responsible use, preserve broad access, and improve patient care.

The Pharmacogenomics Best Practices statement builds from the efforts of the AMP Pharmacogenetics (PGx) Working Group, which is working on a series of evidence-based expert consensus opinion recommendations designed to help standardize alleles that should be included in clinical testing for frequently used genotyping assays. Together with organizational representation from Clinical Pharmacogenetics Implementation Consortium (CPIC) and the College of American Pathologists (CAP), the AMP PGx Working Group has published recommendations for selection and genotyping of CYP2C19 and CYP2C9 alleles used in clinical assays. There are two additional expert opinion recommendations in development.

Additional Recent Comment Letters:

Joint Comments on Preliminary Local Coverage Determination: MolDX: Pharmacogenomic Testing. Submitted to CGS, Noridian, and Palmetto – November 21, 2019

Joint Comments on Preliminary Local Coverage Determination: MolDX: Repeat Germline Testing. Submitted to CGS, Noridian, and Palmetto – November 21, 2019

Joint Comments on Preliminary Local Coverage Determination: MolDX: Erythrocyte Molecular Antigen Typing. Submitted to CGS, Noridian, and Palmetto – November 21, 2019

Updated List of Signers: Coalition Letter Opposing Draft Legislation of Section 101 of the Patent Act – July 25, 2019

Joint Comments on Proposed Local Coverage Determination: Gastrointestinal Pathogen (GIP) Panels Utilizing Multiplex Nucleic Acid Amplification Techniques (NAATs) – August 11, 2019

Group Stakeholder Letter in Support of the Improving Seniors’ Timely Access to Care Act of 2019 (HR 3107) – September 9, 2019

AMP Expressed Support for Proposed Legislation to Ameliorate Effects of PAMA – October 16, 2019

The AMP EAC and PRC work diligently to provide input to Congress and relevant agencies on all issues affecting regulation and reimbursement of molecular procedures. You can review all recent comment letters here.