The market has recently witnessed an acceleration of several new classes of drugs that were approved by the FDA. With specialty drug spending showing no signs of slowing down and the drug pricing debate raging in Congress, what are the current drugs in the specialty pipeline that stakeholders can take advantage of? Most importantly what policies are being developed that will govern accessibility and reimbursement for manufacturer, specialty and home infusion stakeholders?
In this recorded webinar, Ronald W. Lanton III, Esq., Executive Director of Frier Levitt Government Affairs, discusses: • Overview of current policy • Discussion of upcoming possible blockbuster medications • Examination of market trend opportunities • Guidance on next steps
By the end of this presentation, participants will be able to: • Understand the current policy in place • Identify new possible blockbuster medications in the specialty pipeline • Comprehend new developing policies that will govern accessibility and reimbursement for manufacturer, specialty and home infusion stakeholders
The Centers for Medicare and Medicaid Services (CMS) has issued a notice in the Federal Register on the previously debated home infusion rule. The rule originally proposed in July focused primarily on two sections, “Requirements for Home Infusion Suppliers” and “Accreditation for Home Infusion Therapy Suppliers.” The rule as written has the potential to drive Medicare and Medicaid beneficiaries to more hospitals and nursing home visits, thus increasing costs.
The “Requirements for Home Infusion Suppliers” section has caused the most industry concern since it includes definitions for an infusion drug administration calendar day and the required services of a home infusion supplier. This part of the rule states:
“Therefore, we proposed to define in regulation that ‘infusion drug administration calendar day’ refers to payment for the day on which home infusion therapy services are furnished by skilled professional(s) in the individual’s home on the day of infusion drug administration. As we stated in the proposed rule, we believe this to mean skilled services as set out at 42 CFR. 409.32. This regulation states that the skilled services furnished on such day must be so inherently complex that they can only be safely and effectively furnished by, or under the supervision of, professional or technical personnel.”
The new final rule also describes how CMS will maintain its prior proposed limit on reimbursement to “the day on which home infusion therapy services are furnished by skilled professionals in the individual’s home.” Additionally, the final rule summarizes the case-mix methodology refinements for home health services beginning on or after January 1, 2020, which includes the elimination of therapy thresholds for payment and a change in the unit of payment from a 60-day episode to a 30-day period. These final rule changes are materially negative to private home infusion companies.
Fortunately, CMS is allowing the industry one last chance to issue comments on this final rule. The comment period ends on December 31, 2018.
This is the industry’s last opportunity to voice concerns to CMS regarding the negative impact of this final rule. Frier Levitt Government Affairs, LLC (FLGA) can help practices formulate their concerns to send to CMS, as well as help create a strategy if CMS maintains its position. Contact FLGA today to plan your next steps before the December 31st deadline.