On November 2, the FDA granted accelerated approval to lorlatinib (Lorbrena, Pfizer Inc.) for patients with ALK+ metastatic non-small cell lung cancer (NSCLC) whose disease has progressed on crizotinib and at least one other ALK inhibitor for metastatic disease or whose disease has progressed on alectinib or ceritinib as the first ALK inhibitor therapy for metastatic disease.
Read the full FDA press release here.
On November 2, the Centers for Medicare & Medicaid Services (CMS) released the final calendar year (CY) 2019 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System rule.
Download the final 2019 OPPS rule from the Federal Register here.
Highlights from the CMS fact sheet on the final rule include:
For more information, access the CMS fact sheet on the final CY 2019 OPPS rule here.
ACCC is currently reviewing the final 2019 OPPS rule and will provide an in-depth analysis to membership shortly.
For CY 2021, CMS would move forward to reduce payment variation for E/M office/outpatient visit levels by paying a single rate for visit levels 2 through 4 for established and new patients, "while maintaining the payment rate for E/M office/outpatient visit level 5 to better account for the care and needs of complex patients."
For 2019, CMS finalized its proposal to pay separately for two newly defined physicians’ services furnished using communication technology:
Payment Rates for Non-excepted Off-campus Provider-Based Hospital Departments Paid Under the PFS
Since CY 2017, payment for certain items and services furnished in non-excepted off-campus provider-based departments has been made under the PFS using a PFS Relativity Adjuster based on a percentage of the OPPS payment rate. The PFS Relativity Adjuster in CY 2018 is 40 percent, i.e., non-excepted items and services are paid 40 percent of the amount that would have been paid for those services under the OPPS.
For CY 2019 CMS is finalizing that the PFS Relativity Adjuster remain at 40 percent.
Wholesale Acquisition Cost (WAC)-Based Payment for Part B Drugs: CMS Finalizes Reduction of Add-on Amount
Effective Jan. 1, 2019, WAC-based payments for Part B drugs determined under section1847A of the Social Security Act, during the first quarter of sales when average sales price (ASP) is unavailable, will be subject to a 3 percent add-on in place of the current 6 percent add-on. The agency reiterated that these changes only apply to WAC-based payment for new Part B drugs.
ACCC is analyzing the final rule and will provide in-depth analysis to the membership soon.
View the CY 2019 Physician Fee Schedule and Quality Payment Program final rule here.
Access the CMS fact sheet on the CY 2019 Physician Fee Schedule final rule.
Access the CMS fact sheet on the CY 2019 Quality Payment Program final rule.
On Thursday, October 25, the Trump Administration released of a three-pronged proposal to overhaul Medicare Part B and tackle rising drug costs. ACCC looks forward to commenting on this proposal, but the Administration's actions are still in the nascent stages of development. An Advance Notice of Proposed Rulemaking (ANPRM) was released on October 25, with expectation that a formal proposed rule would be released in Spring 2019. Many questions are yet to be addressed regarding the intricacies in implementation of this model.
Under the proposal the Medicare Part B landscape would change significantly through the use of a mandatory demonstration through the Center for Medicare and Medicaid Innovation (CMMI) with an International Pricing Index (IPI) model.
In a policy statement, the Association of Community Cancer Centers (ACCC) expresses overarching concerns about the impact of the proposal on the entire cancer care delivery infrastructure and, in particular, those programs and practices that see a high percentage of Medicare, Medicare only, and dual-eligible patients. ACCC urges policymakers to be aware that this policy has the potential to drastically hamper access to vital patient care and harm innovation for cancer care treatment.
ACCC looks forward to working with the Centers for Medicare & Medicaid Services (CMS) to ensure that any model put forth to the public is voluntary, maintains appropriate safeguards for access to patient care, and drives increased value-based propositions for the oncology community.
President Trump is expected to make an announcement this afternoon, October 25, detailing continued reform efforts in lowering drug prices. The proposal to be released this afternoon would use the Center for Medicare & Medicaid Innovation center to test three ways of lowering the cost of drugs in Medicare Part B. A report released from the Department of Health & Human Services, Office of the Assistant Secretary for Planning and Evaluation (ASPE) advocates for the reform of Medicare Part B to align more with the negotiation and utilization management tactics currently utilized in Medicare Part D.
Stay tuned for more updates from the ACCC Policy Team.
Health and Human Services Secretary Alex Azar yesterday outlined updates to HHS’s “four strategies” for addressing prescription drug pricing in remarks delivered during the National Academy of Medicine’s President’s Forum on Affordable Medicines: Access, Innovation, and the Public Interest.
In his address, Secretary Azar called attention to the proposed rule issued yesterday by the Centers for Medicare & Medicaid Services (CMS) that would require manufacturers to include in their direct-to-consumer TV advertising the list price of drugs paid for by Medicare & Medicaid. While acknowledging a pharmaceutical industry announcement yesterday of an initiative to improve price transparency, Secretary Azar stated that HHS “will not rely on voluntary action to accomplish our goals.”
Secretary Azar’s speech centered on HHS’ four areas of drug-pricing focus under the Administration's blueprint for lowering drug prices released last May: negotiation, reducing consumer out-of-pocket costs, improving competition, and creating incentives for lower list prices. In his remarks, Secretary Azar highlighted specific actions the administration has taken to date and outlined possible future steps in each of the four areas.
The full text of Secretary Azar's address is available here.
ACCC policy staff will provide a more in-depth look at Secretary Azar's remarks shortly.