On September 17, the Centers for Medicare & Medicaid Services (CMS) released the Medicare & Medicaid; Regulatory Provisions to Promote Program Efficiency, Transparency, and Burden Reduction proposed rule for calendar year 2019. This proposed rule was released to build upon the administration’s ‘Patients Over Paperwork’ and ‘Cut the Red Tape’ initiatives. The deadline for submitting comments on the proposed rule is 60 days from the rule's release into the US Federal Register.
ACCC is currently analyzing the rule and will provide an update to members soon.
View the proposed CY 2019 rule.
The Centers for Medicare & Medicaid Services (CMS) have announced efforts underway to support North Carolina and South Carolina in response to Hurricane Florence. CMS is working to ensure hospitals and other facilities can continue operations and provide access to care despite the effects of Hurricane Florence. CMS has waived certain Medicare, Medicaid, and Children’s Health Insurance Program (CHIP) requirements; created special enrollment opportunities for individuals to access healthcare immediately; and taken steps to ensure dialysis patients obtain critical services.
For more information, visit www.cms.gov/emergency.
On September 12, the American Association for Cancer Research (AACR) released its annual Cancer Progress Report highlighting how federally funded research discoveries are fueling the development of new and even more effective ways to prevent, detect, diagnose, and treat cancer.
Key advances outlined in the AACR Cancer Progress Report 2018 include the following:
Read the full Cancer Progress Report for more information.
On Wednesday, August 29, 2018, the Centers for Medicare & Medicaid Services (CMS) issued a memo to Medicare Part D plans that will allow these plans to implement “indication-based formulary design” starting in 2020.
Currently, if a Part D plan includes a specific drug on its formulary, the plan must cover that drug for every FDA-approved indication, or patient condition, even if the plan would otherwise instead cover a different drug for a particular indication.
The CMS memo states that if a Part D plan limits formulary coverage of a drug to certain indications, the plan must ensure that there are other therapeutically similar drugs on formulary for the drug’s non-covered indications.
The ACCC policy team is currently reviewing this policy change.
Read the CMS memo to Part D plans.
Read the agency's fact sheet.
Pembrolizumab was previously granted accelerated approval for this indication in May 2017 based on improvements in overall response rate and progression-free survival for patients randomized to pembrolizumab administered with pemetrexed and carboplatin as compared with pemetrexed and carboplatin alone in the KEYNOTE-021 study. This approval represents fulfillment of a postmarketing commitment demonstrating the clinical benefit of this product.
Read the full FDA announcement here.