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Photo of Posts by Katrina A. Pagonis Katrina A. Pagonis
Partner
kpagonis@health-law.com
415.875.8515
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Showing 8 posts by Katrina A. Pagonis.

On Thursday, the President held a White House event to discuss surprise medical bills, calling on Congress to pass bipartisan legislation to increase price transparency and limit patients’ out-of-pocket medical costs.  During his remarks, President Trump outlined the following policy principles to guide Congress in developing potential legislation: 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 ›

CMS Proposes Changes to Telehealth Reimbursement, Stark, Substance Use Disorder Treatment Reimbursement, and Evaluation & Management Reimbursement in the  CY 2019 Physician Fee Schedule Proposed Rule

On Thursday, July 12, 2018, the Centers for Medicare & Medicaid Services (CMS) released the 2019 Physician Fee Schedule (PFS) Proposed Rule (the Proposed Rule). Read More ›

On April 27, 2018, the U.S. Department of Health and Human Services, Department of Labor, and the Treasury Department (collectively the Departments) issued a “Clarification” of its previously-issued Greatest of Three (GOT) rule regarding payment for out-of-network emergency services.  While the immediate impetus was a court order requiring the Departments to clarify the basis for the GOT rule, the Departments have provided valuable guidance that will assist providers in challenging the level of payment for such services. Read More ›

This week, the U.S. Senate and House of Representatives passed the Tax Cuts and Jobs Act (the Act), which now heads to the President’s desk for his signature.  Read More ›

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