The market for direct-to-consumer (“DTC”) genetic testing has increased dramatically over recent years as more people are using at-home DNA tests. The global market for this industry is projected to hit $2.5 billion by 2024. Many consumers subscribe to DTC genetic testing because they can provide insights into genetic backgrounds and ancestry. However, as more consumers’ genetic data becomes available and is shared, legal experts are growing concerned that safeguards implemented by U.S. companies are not enough to protect consumers from privacy risks.
Some states vary ...
Following a two-day meeting by a Food and Drug Administration (“FDA”) advisory committee on breast implant safety earlier this year, FDA on May 2, 2019, released a statement announcing that no breast implant models will be banned from the U.S. market at this time. Also described in the statement are a number of measures the agency is undertaking in order to assist women in making more informed decisions regarding breast implants.
The March 26, 2019, meeting of the General and Plastic Surgery Devices Panel was convened to discuss issues and concerns related to the benefit-risk ...
On March 27, 2019, the FDA announced that it would be proposing new amendments to key regulations regarding mammography facilities that would require these entities “to tell women more about how dense breast tissue can affect their health and increase their cancer risk.” The proposed changes to mammography facility regulations would be the first issued in more than 20 years. The FDA believes the change will “expand the information mammography facilities must provide to patients and health care professionals, allowing for more informed medical decision-making.” In ...
On March 15, 2019, the Centers for Medicare & Medicaid Services (CMS) released proposed changes to its methodology for calculating Civil Money Penalties (CMPs) for Medicare Advantage (MA) and Part D Prescription Drug Plan (MA and Part D) sponsors. The proposed changes would impact both the calculation methodology for 2019 as well as the CMP amounts for 2019 and beyond in an effort to increase plan accountability. CMS is accepting comments on these proposed changes until April 15, 2019 at 11:59 PM ET.
Though CMS has exercised its statutory and regulatory authority to impose CMPs on MA ...
The Medicare Payment Advisory Commission (“MedPAC”) held its monthly public meetings in Washington, D.C., on November 1-2, 2018. The purpose of this and other MedPAC public meetings is for the commissioners to analyze existing challenges and issues within the Medicare program and to provide future policy recommendations to Congress. MedPAC issues these recommendations in two annual reports, one in March and another in June. These meetings offer a comprehensive perspective on the current state of Medicare as well as future outlooks for the program.
As thought leaders in ...
The Medicare Payment Advisory Commission (“MedPAC”) met in Washington, D.C., on September 6-7, 2018. The purpose of this and other public meetings of MedPAC is for the commissioners to analyze existing challenges and issues within the Medicare program and to provide future policy recommendations to Congress. MedPAC issues these recommendations in two annual reports, one in March and another in June. These meetings offer a comprehensive perspective on the current state of Medicare as well as future outlooks for the program.
As thought leaders in healthcare law, Epstein ...
Blog Editors
Recent Updates
- Interested in Opening a Medical Spa? Here’s What You Need to Know
- Podcast: Key Changes in Finalized Antitrust Merger Guidelines – Diagnosing Health Care
- FDA Releases Draft Guidance on New Dietary Ingredient Notification Master Files for Dietary Supplements
- Updated Requirements for Informed Consent: HHS Issues New Guidance on Sensitive Exams
- Importance of Negotiating Assignment and Subletting Provisions in Health Care Leases