{ Banner for HLB Health Law & Policy Blog }

Search

Get updates

Blog Contributors

Archived Blog Posts

Showing 4 posts from March 2019.

Hooper Lundy is pleased to announce that Jeremy D. Sherer was recognized by the American Bar Association’s Health Law Section with an Emerging Young Lawyers in Healthcare Award at the 20th Annual Emerging Issues in Healthcare Conference  on March 13-16, 2019 at the JW Marriott in Orlando, Florida. The ABA recognized Jeremy for a broad range of achievement, vision, leadership, and legal and community service in health law. The award was presented by the Section Chair, Alexandria Hien McCombs, during her State of the Section presentation on Friday, March 15, 2019

On February 22, 2019, the Centers for Medicare & Medicaid Services (“CMS”) and the Office of the National Coordinator for Health Information Technology (“ONC”) of the Department of Health and Human Services (“DHHS”) formally issued two proposed rules and related Requests for Information (RFIs) intended to advance interoperability and increase patient access to health information (the “CMS Proposed Rule” or “Proposed Rule” and the “ONC Proposed Rule,” respectively).   This alert focuses on the CMS Proposed Rule, while a subsequent client alert will address the ONC Proposed Rule. Read More ›

On Friday, February 15, 2019, CMS released a proposed decision memo to cover FDA-approved Chimeric Antigen Receptor (CAR) T-cell therapy, which uses a patient’s immune system T-cells to fight certain types of blood cancers, pursuant to a Coverage with Evidence Development (CED). Two CAR T-cell products are currently approved by the FDA for treatment of certain patients with relapsed or refractory acute myeloid leukemia and large B-cell lymphoma. In addition, multiple clinical trials involving CAR T-cell therapies are currently underway across the country, including FDA-required post-approval studies. There is no national Medicare policy currently regarding coverage for this therapy, and local Medicare Administrative Contractors currently determine whether to pay for it.

This announcement by CMS appears to be a generally positive development for stakeholders seeking more clarity regarding parameters for coverage of the therapy. If adopted, the CED does ensure coverage on a national basis for the near future for certain types of CAR T-cell therapy under certain conditions, and during that time stakeholders can continue to gather additional data to support an argument for broader coverage as appropriate, as well as to support an argument for an appropriate reimbursement methodology. Read More ›

A new round of putative class action lawsuits brought by counsel for patients who received treatment in a hospital emergency room alleging that hospitals charge emergency room patients a hidden and undisclosed “surcharge” or “cover charge” on top of charges for services provided is hitting hospitals throughout California. These suits are the progeny of prior unsuccessful putative class action lawsuits brought by the same plaintiff’s counsel alleging that hospitals’ charges for emergency services are unreasonably high and that the financial arrangements provision within the Conditions of Admission agreement signed by the patients requiring payment of charges are improper and not enforceable. Read More ›

For media assistance, please contact Maura Fisher at 202-580-7714.