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Photo of Posts by Amy M. Joseph Amy M. Joseph
Partner
ajoseph@health-law.com
617.532.2702
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Showing 14 posts by Amy M. Joseph.

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 ›

On December 14, 2018, the Department of Health and Human Services (“HHS”) issued a request for information (“RFI”), asking for feedback on how to change certain regulations issued pursuant to the Health Insurance Portability and Accountability Act (“HIPAA”). The RFI seeks information on how best to remove obstacles to efficient care coordination while also protecting patients’ health information, as well as how to encourage providers to share information for treatment and care coordination, making it easier to share information with parents and caregivers in dealing with the opioid crisis. Comments or information regarding changes to the HIPAA regulations must be submitted to HHS on or before February 12, 2019. Then, the agency will still need to go through the regulatory rulemaking process to implement any proposed changes after the RFI process is complete. Read More ›

On Friday, December 21, 2018, CMS issued a final rule, referred to as “Pathways for Success,” that makes significant changes the Medicare Shared Savings Program. Issued just before the holidays, various stakeholders will likely have varying opinions about whether this final rule constituted an early gift or lump of coal. Among other things, the final rule overhauls the current track system for participating accountable care organizations, or ACOs, and requires a more rapid transition to assumption of downside risk. The two new tracks available to participating ACOs will go into effect for agreement periods commencing on or after July 1, 2019. Read More ›

With an implementation date of July 1, 2019 for updates to the Accreditation Council for Graduate Medical Education’s (ACGME) Common Program Requirements (the basic set of standards for training resident and fellow physicians), teaching hospitals should be proactively reviewing and making appropriate changes to their graduate medical education (GME) programs over the next several months to ensure compliance moving forward. Read More ›

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