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Showing 5 posts in Clinical Research.

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 ›

Beginning October 2, 2018, California health care professionals authorized to prescribe, order, administer or furnish controlled substances must consult the state’s prescription drug monitoring database (the Controlled Substance Utilization Review and Evaluation System, or CURES) prior to prescribing, ordering, administering or furnishing Schedule II-IV controlled substances, unless an exemption applies.[1]  The duty to consult takes effect almost two years after the law was initially enacted, and six months after the California Department of Justice (DOJ) certified CURES as ready for statewide use. Read More ›

On July 25, 2018, the Office for Human Research Protections (OHRP) announced the availability of three draft guidance documents related to implementation of three burden-reducing provisions of the revised Federal Policy for the Protection of Human Subjects (Revised Common Rule). Read More ›

The sixteen federal agencies responsible for protecting human subjects of federally-funded research issued a final rule to modernize the Federal Policy for the Protection of Human Subjects on January 19, 2017 - the last day of the outgoing Administration. This is the first comprehensive overhaul of the so-called "Common Rule," which was issued in 1991 to create a uniform set of standards governing federally funded or sponsored research involving human subjects. Read More ›

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