The rule finalizes new policies aimed at giving patients access to their health information, using CMS's authority to regulate Medicare Advantage (MA), Medicaid, CHIP, and Qualified Health Plan (QHP) issuers on the Federally-facilitated Exchanges (FFEs). Currently these data are held by health insurers, hospitals, and vendors of electronic health records (EHRs).
New policies include:
On March, 2, 2020, the U.S. Food and Drug Administration (FDA) approved Sarclisa® (isatuximab-irfc) in combination with pomalidomide and dexamethasone (pom-dex) for the treatment of adults with relapsed refractory multiple myeloma (RRMM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor. Sarclisa is expected to be available to patients in the U.S. shortly.
Sarclisa is a monoclonal antibody that binds to the CD38 receptor on multiple myeloma cells.
Sarclisa has Orphan Drug Designation status from the FDA.
Read corporate press release.
The College of American Pathologists (CAP), the American Society of Clinical Oncology (ASCO), the Association for Molecular Pathology, and Fight Colorectal Cancer are collaborating to develop clinical guidelines for testing DNA mismatch repair (MMR) and microsatellite instability (MSI) status in patients with a range of cancers.
The groups have opened the public comment period for the guideline “MMR and MSI Testing in Patients Being Considered for Checkpoint Inhibitor Therapy.” Find details, including background information, recommended resources to review before providing comments, and overarching questions for consideration here.
All stakeholders—including pathologists who refer and perform molecular testing, oncologists, laboratory personnel, and allied health professionals—are encouraged to provide feedback on the draft recommendations to ensure the final recommendations are clinically practical. The comment period runs from February 19 to March 13, 2020.
The Association of Community Cancer Centers (ACCC) joined in a wide coalition letter to congressional leadership urging that Congress include the bipartisan Clinical Treatment Act (H.R. 913) in the Healthcare Extenders Package that is likely to pass this spring.
Passage of the Clinical Treatment Act would guarantee that routine care costs of clinical trial participation would be covered for Medicaid beneficiaries with a life-threatening condition. Currently, Medicaid is not federally required to cover these clinical trial associated costs.
Because these costs only encompass non-experimental costs of treating patients (e.g., doctor's visits and lab work) on clinical trials, the Clinical Treatment Act would not significantly affect overall cost to Medicaid programs.
Read coalition letter.
On Feb. 5, 2020, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule and Advance Notice Part II.
The CY 2021/2022 Medicare Advantage and Part D Proposed Rule (CMS- 4190-P) would:
Download Medicare Advantage and Part D Advance Notice Part II.
The Centers for Medicare & Medicaid Services (CMS) is hosting a webinar on Wednesday, February 12 at 2:30 pm ET to provide an overview of the MIPS Value Pathways (MVPs) participation framework thats outlined in the 2020 Quality Payment Program Final Rule. CMS is committed to co-developing the MIPS Value Pathways with stakeholders and the public, and will be using this webinar to answer questions from organizations interested in providing input on MVPs.
The webinar will:
MIPS Value Pathways Webinar
Wednesday, February 12, 2020
2:30 – 3:30 pm ET
NOTE: This webinar will only cover existing information about the MIPS Value Pathways, as found within the 2020 Final Rule, MVPs webpage, and accompanying materials such as the MVPs fact sheet and illustrative diagrams. No new information about the MVPs will be presented during the webinar.