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April 12, 2016
Senate Committee Approves Medical Innovations, Precision Medicine Legislation
Legislation to support and advance precision medicine and new medical innovations is moving forward in the Senate after the Health, Education, Labor, and Pension (HELP) Committee passed several bills during an April 6 markup session.
The CAP continues to engage with the HELP Committee as they plan to merge the 19 bills into a larger medical innovation package for debate on the Senate floor. The majority of the bills focus on streamlining the regulatory pathway for medical devices and drugs to the marketplace.
The legislative package includes S. 2713, Advancing Precision Medicine Act of 2016, that supports President Obama's initiative to map 1 million genomes and making the information available to researchers who in turn will be required to share their research to help find treatments for diseases sooner.
Additionally, there are proposals that still need be to negotiated before the package is brought to the Senate floor for debate. Senate Democrats have publicly said they would not support the medical innovations package without a boost in mandatory funding for the National Institutes of Health (NIH) that supports President Obama's precision medicine initiative, and "cancer moonshot" project. The House 21st Century Cures bill included $8.75 billion in mandatory NIH and Food and Drug Administration funding. HELP Committee Chair Lamar Alexander (R-TN) said he will continue to work with Democrats to find a compromise on an increase in the mandatory NIH funding that supports President Obama's initiatives.
Proposals also would give the FDA authority to conditionally approve cellular therapies, and improve post-market monitoring of medical devices.
Medical innovation bills marked up by the HELP Committee include:
- The Advancing Targeted Therapies for Rare Diseases Act of 2015 to help advance therapies to patients with serious or life-threatening rare genetic diseases by allowing innovators to rely on their own data used for previously approved targeted therapies to develop subsequent targeted therapies.
- Advancing Research for Neurological Diseases Act of 2015 to advance our understanding of neurological diseases and help researchers access data on these diseases in order to discover new therapies and cures.
- Improving Health Information Technology Act to address interoperability, decrease unnecessary physician documentation, enable patients to have easier access to their own health records, make electronic health records more accessible to the entire health care team.
- Advancing NIH Strategic Planning and Representation in Medical Research Act to require the NIH to come up with a strategic plan every six years, and also helps ensure that scientists are including women and minorities in their research and reporting on the differences they find.
- Patient Focused Impact Assessment Act of 2015 to give patients and their families a voice in the FDA-approval process.
- Promoting Biomedical Research and Public Health for Patients Act to allow researchers at the NIH to spend more time finding life-saving treatments and cures and less time on paperwork.
- Next Generation Researchers Act to attract talented young scientists to the NIH.
Offsets for the Senate Innovations package could be a significant obstacle in the Senate chamber. Senate Finance Chair Orrin Hatch (R-UT) has stated that his committee could find offsets, but he did not offer details.
In July 2015, the House passed its 21st Century Cures Act legislation to advance medical innovations and modernize clinical trials. The bill reauthorizes funding for the NIH through fiscal 2018, establishes an NIH Innovation Fund, and requires the FDA to issue guidance that would assist in the development of biomarkers and precision drugs and biological products, and support expedited approval of breakthrough therapies.
Although the HELP Committee has yet to reach agreement on a provision addressing regulatory oversight of laboratory-developed tests (LDTs), Sen. Alexander said legislative language on LDTs could still make it into final the bill. The CAP remains engaged with the Senate, as well as the House Energy and Commerce (E&C) Committee, on LDT oversight.
CMS Chief of Staff to Provide Insights on Medicare Payment at CAP Policy Meeting
A top ranked official for the Centers for Medicare & Medicaid Services (CMS) will speak about certain Medicare policies affecting pathologists during the 2016 CAP Policy Meeting May 2-4 in Washington, DC.
The CAP Policy Meeting is a benefit of CAP Membership and there is no fee to register for the meeting. The 2016 event will include meetings with members of Congress during the CAP's Annual Hill Day on May 4. The annual meeting is the specialty's opportunity to focus and engage on the federal issues most important to pathologists.
During the 2016 CAP Policy Meeting, CMS Chief Operating Officer and Chief of Staff Mandy Cohen, MD, MPH will participate for a panel discussion on physician policies impacting reimbursement and the provision of services in the public and private marketplaces. She will be joined by John Yao, MD, MBA, MPH, MPP, FACP, who is staff-vice president of medical policy development and technology assessment at Anthem, Inc., and CAP Economic Affairs Committee Chair Jonathan L. Myles, MD, FCAP.
Collaborate. Advocate. Take Action.
Other speakers and participants at the Policy Meeting will include:
- Harold D. Miller, the president and CEO of the Center for Healthcare Quality and Payment Reform and nationally-recognized expert on health care payment and delivery reform, who will discuss how physician can provide leadership in future health care payment and delivery reform
- Marc Hartstein, the director of the Centers for Medicare & Medicaid Services (CMS) Hospital Ambulatory Payment Group, and Medicare law and policy authority Paul Radensky, MD, JD, of the law firm McDermott Will & Emery. Mr. Hartstein and Dr. Radensky will speak during a panel discussion titled: "Getting Ready for the New Protecting Access to Medicare Act (PAMA) Requirements for Laboratories."
- Alberto Gutierrez, PhD, Director of the Food and Drug Administration (FDA) Office of In Vitro Diagnostics in the Radiological Health Center for Devices and Radiological Health, who will be part of a panel discussion on oversight of laboratory-developed tests (LDTs).
- Renowned journalist David Gregory and leading public opinion experts and pollsters who will discuss current events and the upcoming presidential race for the White House.
Join your colleagues at the 2016 CAP Policy Meeting in Washington, DC by registering for the Policy Meeting today.
Complete the Practice Leader Survey by April 13
To accommodate for spring vacation schedules, the CAP is holding the 2016 Practice Leader Survey open until April 13 to gather additional responses from individual pathology practices regarding their economics, demographics, and market trends.
If you have started to participate in the survey but were unable to complete it, you still have the ability to finish your survey. Your practice's participation is vital to help keep our profession at the forefront and support our advocacy efforts. After completing the survey, you will receive early access to the results that can help your practice understand the latest trends within pathology practices. You also will be eligible to win an Apple Sport Watch or one of two $100 Amazon gift cards.
Practices with more than one practice leader should coordinate about how to best complete one survey for their practice. For a listing of the specific questions on the survey, please email practicesurvey@cap.org.
All responses are kept strictly confidential. Responses will be reported in aggregate form only. No individual practice information will be uniquely identified or shared.
Final Reminders Emailed to Practices on April 11
Pathology practice leaders began receiving invitations to complete the survey on March 21 and reminders were sent on April 11. CAP members who complete the survey, which should take about 20 minutes to complete, will later receive an invitation to attend an exclusive webinar reviewing the survey results. A report on the survey will then be available for all CAP members.
Those completing the survey will receive early access to the results. The CAP will publish more details about this and other benefits for completing the survey.
CAP Engages with FDA on NGS Oncology Panels, Precision Medicine
The CAP continues to engage with the Food and Drug Administration (FDA) on next-generation sequencing (NGS) as the agency is studying patient and provider perspectives on NGS and potential regulatory standards for oncology panels.
In March 28 comments regarding NGS oncology panels to the FDA, the CAP responded to a list of questions about intended use statements, pre-analytical and quality metric approaches, analytical validation and bioinformatics, and clinical and follow-on companion diagnostic claims. The CAP's response focused on additional issues that are unique to the pre-analytical and quality metric approaches that were the topic of an FDA workshop on February 25. The CAP had also participated during the public workshop.
Read the CAP's comments on NGS oncology panels.
CAP Engages on Precision Medicine Initiative
As part of President Obama's Precision Medicine Initiative, the FDA is considering new approaches in its regulation of NGS. The FDA is interested in promoting innovation while ensuring that patients have access to cutting edge technologies that are accurate and provide meaningful information to inform their health care decisions.
After a March 2 FDA public workshop discussing patient and medical professional perspectives on genetic test results, the CAP followed with a March 31 letter to the agency discussing the role pathologists play in providing genetic test results to patients and resources available to pathologists.
"The CAP holds that patients are best served generally when a qualified physician orders laboratory tests where such a physician directs the course of the diagnostic and therapeutic care of the patient, and that a physician should determine which clinical and anatomic laboratory services are appropriate," the CAP stated. "We agree that engagement with patient groups on how genetic results should be interpreted and returned in various testing scenarios such as well-person predictive testing (APOE, BRCA1/2), somatic mutation testing in oncology, pharmacogenetic testing and direct to consumer (DTC) genetic testing is critical for optimal patient care."