This Week in Managed Care: January 31, 2020

The Trump administration unveils its plan for Medicaid block grants, federal officials respond to the coronavirus, and FDA offers guidance for gene therapies.

Welcome to This Week in Managed Care, I’m Matthew Gavidia.

CMS Gives States Leeway With Medicaid Block Grants

On Thursday, the administration followed through on a long-planned goal to let states received a fixed payment for able-bodied adults in the program.

Published reports say CMS Administrator Seema Verma has been working on the plan for more than a year.

The American Society of Clinical Oncology said setting annual limits on Medicaid could have devastating consequences on patients with cancer. Said ASCO President Dr Howard Burris, “A transition to block grants could transform Medicaid from a safety net program, designed to meet basic health needs for low-income Americans, to a program with funding limits that drive care rationing for the most vulnerable. ASCO supports Medicaid reform, but such efforts—whether at the national, state, or local levels—must allow individuals to have access to high-quality cancer care without interruption.”

The plan follows a separate effort to allow states to require poor Americans to work or enroll in training programs to receive qualify for Medicaid. Those plans have been challenged in court.

For more, visit ajmc.com.

HHS Issues Updates on Novel Coronavirus

HHS Secretary Alex Azar offered an update this week on the government’s response to the 2019 novel coronavirus, which had killed more than 132 people in China as of Wednesday.

Azar said the State Department, the FDA, the National Institutes of Health, and the CDC are working together to develop tests for the virus, to find treatments, and to halt the spread of disease. Said Azar: “Americans should know that this is a potentially a very serious public health threat, but at this point, Americans should not worry for their own safety.”

The 130 deaths reported in China come from 4500 confirmed cases, and those who have died were older or had other illnesses. There have been concerns the disease can spread before symptoms appear.

But Dr Anthony Fauci, the nation’s top infectious disease expert, said this is unlikely to cause most cases. “The one thing people historically need to realize is that even if there is asymptomatic transmission, in all the history of respiratory-borne illnesses of any type, asymptomatic transmission has never been the driver of outbreaks.”

FDA Releases Framework for Assessing Gene Therapies

FDA this week released 6 final guidance documents for gene therapy development and 1 draft document, as the agency prepares for the tidal wave of new products in the pipeline.

Said FDA Commissioner Dr Stephen Hahn, “The growth of innovative research and product development in the field of gene therapy is exciting to us as physicians, scientists, and regulators.…These therapies, once only conceptual, are rapidly becoming a therapeutic reality for an increasing number of patients with a wide range of disease, including rare genetic disorders and autoimmune diseases.”

The documents finalized this week include specific guidance for hemophilia, retinal disorders, and rare diseases, as well as information on manufacturing, testing, and patient follow-up.

The draft guidance concerns interpreting the sameness of gene therapies under FDA’s orphan drug designation.

For more, visit our sister site, The Center for Biosimilars^®.

CMS Agrees to Cover NGS for Medicare Patients With Breast, Ovarian, Other Cancers

CMS on Monday said it would start paying for next-generation sequencing for patients with germline breast and ovarian cancer. But an advocacy group said the announcement isn’t as rosy as it appears.

Said CMS Administrator Seema Verma: “We’re leaving no stone unturned in supporting women’s health and getting all patients the care they need. NGS testing provides clinically valuable information to guide patients and physicians in developing a personalized treatment plan.”

However, wording in the National Coverage Determination says the diagnostic test using NGS must have “Food and Drug Administration (FDA) approval or clearance.”

Lisa Schlager of FORCE contacted AJMC to explain that no current NGS diagnostic meets this standard, so this is a setback for women with breast and ovarian cancer.

For more, visit ajmc.com.

Podcast Discusses Why Biomarker Testing in Advanced Colon Cancer Is Still Lagging

The need for broad-based genomic testing was the subject of our recent Managed Care Cast with Dr Stuart Goldberg, who serves as chief of the Division of Value and Outcomes Research at the John Theurer Cancer Center.

In the podcast, Dr Goldberg discusses surprising results he and fellow researchers reported in JCO Precision Medicine, which showed that oncologists are not keeping up with all the known biomarkers in colon cancer.

You can listen to this edition of Managed Care Cast where you find your podcasts.

Paper of the Week

Welcome to Paper of the Week, which looks back at research and commentary from the past 25 years in The American Journal of Managed Care^®, and why they matter today. This week’s paper comes from our own editors in chief, Drs Mark Fendrick and Michael Chernew, who in 2001 presented the idea of tying a drug co-pay to its clinical value to the patient.

This concept, presented in the paper, “A Benefit-Based Copay for Prescription Drugs: Patient Contribution Based on Total Benefits, Not Drug Acquisition Cost,” is a foundation of value-based insurance design, which both have examined for the past 20 years, including through The University of Michigan’s V-BID Center, where Dr Fendrick serves as director.

For the 2001 paper, visit ajmc.com.

For coverage of this week’s V-BID Center webinar, visit ajmc.com.

For all of us at AJMC^®, I’m Matthew Gavidia. Thanks for joining us.