Oncology Newsfeed

FDA Approves Cemiplimab-rwlc for Cutaneous Squamous Cell Carcinoma

FDA Approves Dacomitinib for Metastatic NSCLC

House Approves Legislation Banning Pharmacist “Gag Clauses”

On Tuesday, September 25, 2018, the U.S. House passed by voice vote two Senate bills that ban so-called "gag clauses" which prevent pharmacists from informing consumers when it would cost less to pay out-of-pocket for prescriptions drugs instead of using their health insurance.

On Monday, the U.S. Senate passed two pieces of legislation that would prohibit such "gag clauses." The Patient Right to Know Drug Prices Act, S. 2554, impacts private health plans including those in the ACA marketplace, and the Know the Lowest Price Act of 2018, S. 2553, covers Medicare Advantage and Part D plans. 

FDA Approves Duvelisib for CLL/SLL, FL

ACCC Submits Comments to Proposed 2019 OPPS Rule

On September 24, 2018, the Association of Community Cancer Centers (ACCC) submitted comments to the Centers for Medicare & Medicaid Services (CMS) on the agency's proposed CY 2019 Outpatient Prospective Payment System (OPPS) rule.

In its comments, ACCC recommends that CMS:

• Not finalize its proposal to reduce reimbursement to Wholesale Acquisition Cost (WAC) plus 3 percent for new drugs and biologicals that do not yet have adequate Average Sales Price (ASP) data;


• Not finalize its proposal to reduce payment for separately payable drugs purchased under the 340B program at nonexcepted hospital off-campus provided-based departments;


• Not finalize its proposal to reduce reimbursement to 40 percent of the OPPS rate for certain clinic visits furnished at excepted off-campus provider-based departments;


• Not finalize its proposal to reduce reimbursement to 40 percent of the OPPS rate for service-line expansions at excepted off-campus provider-based departments;


• Clarify how hospital should bill for furnishing certain outpatient services related to CAR T-cell therapies and ensure that hospitals are paid appropriately for furnishing these therapies; and


• Ensure that any model based on Competitive Acquisition Program (CAP) authority is voluntary for all participants, preserves patient access to treatment and provider flexibility, and promotes cost-efficiency through more effective distribution and delivery of drugs and biological rather than utilization management tools.

Pfizer Announces Relief for Cancer Patients Affected by Hurricane Florence

Pfizer Oncology has announced emergency relief protocols to ensure that patients who receive their Pfizer Oncology medicines through the Pfizer Patient Assistance Program and are impacted by Hurricane Florence have continued access to their medications.

Hogan Lovells to Host Webinar on Legal Considerations of Telehealth

• Recent and proposed expansion of Medicare coverage of telehealth services
• State law considerations in providing telehealth
• Fraud and abuse issues in telehealth
• Innovations, future trends, and the evolution of what’s considered “telehealth”

CMS Issues CY 2019 Proposed Rule Aimed at Efficiency, Transparency, Clinician Burden

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.

House of Representatives Passes Transparency Reforms to Medicare LCDs

• Open and recorded Medicare Administrative Contractor (MAC) Carrier Advisory Committee meetings
• Upfront disclosure of evidence MACs consider when drafting an LCD, as well as the rationale they are relying on to deny coverage.
• Additional options for challenging an LCD
• Annual reports to Congress on the number of LCD appeals and actions taken in lieu of the creation of an ombudsman.

FDA Approves New Treatment for Hairy Cell Leukemia