The American Academy of Dermatology Association, which like other groups took exception to CMS’ “insinuation” in its regulatory pre-proposal that physicians select treatments based on reimbursement ahead of patient need, suggested in Dec. 19, 2018, comments to the agency that drugs on the Food and Drug Administration’s drug shortage list be excluded from the list.
It also expressed concerns regarding access if a drug goes without international reference pricing because a manufacturer chooses not to sell in certain countries.
“AADA is concerned that this model could result in patients losing access to some drugs when a distributor and manufacturer are unable to agree on a price,” the group said. Similarly, the lag in setting a reference price after a new product is introduced could also create access issues.
AADA also took issue with the fact that vendors could not offer physicians and hospitals volume-based incentive payments or rebates but did not have the same prohibition from vendors receiving such incentives. “Under this proposal, CMS should prohibit vendors from prioritizing drug availability or excluding some drugs from distribution to physicians based on discounts provided by manufacturers. CMS will need to monitor utilization to ensure access to necessary treatments is not delayed or impeded.”
AADA also wants more clarity in how providers will be selected to participate.
The American College of Rheumatology expressed concern that “the administrative difficulties that would be associated with utilizing vendors could lead some practices to lose the ability to provide infusion services. Specifically, we are concerned that the added administrative burden of proposed interactions with the vendors in the model exceeds any inherent benefits to practice.” It added that CMS needs to look at how a potentially mandatory participation could affect specialty physician shortages.
The ACR made a number of recommendations, including making the IPI model participation voluntary; allowing for an exit for participants if the program is not working for them; providing incentives that could increase gross reimbursement; increasing provider reimbursement to cover the expenses associated with dealing with vendors; and making sure the agency is adequately tracking the effect on patient access.
ASCO used its comments to reiterate previous comments provided to the agency on revising the competitive acquisition program (CAP), a failed program that used third-party vendors as suppliers for Part B drugs. Among its suggestions were making the program voluntary; ensuring it does not result in an aggregate reduction in payments to oncology practices; ensuring a CAP does not result in interruption in care; and restricting its burdensome utilization management requirements.
The Community Oncology Alliance said it is working on an alternative to the IPI model, one that could contain a number of provisions, such as tiered average sales price-based reimbursement; clinically appropriate utilization management techniques; and drug prices that are lowered without artificial international price indexing.
The American Medical Association in Dec. 20, 2018,to the agency outlined a number of principles that any new vendor-based program needs to include, such as being voluntary; providing supplemental payments to cover the cost of special handling and storage of Part B drugs; flexibility to ensure various ordering issues; preventing variation in treatments for patients; and prohibiting vendors from restricting access using utilization management techniques.
The AMA also offered a range of suggestions for the IPI model, including measuring timeliness of deliveries in hours, not days; prohibiting vendors from withholding shipments of subsequent treatments if the initial claim has not been processed; making all treatment options available, even for off-label use; and getting guarantees from vendors on the availability of next-day delivery to any location where the patient is being treated.
Likewise, the AMA suggested that CMS should not set unreasonable deadlines for claims submissions and should provide an adequate number of vendors to ensure choice and access.
“We are also concerned about the impact of the proposed IPI model and its overall impact on costs to physician practices,” the AMA said in its comment letter. “The Administration proposes to allow the vendors to charge administrative fees to physician practices as part of their agreement to provide drug products to those practices included in the model. While we understand that third-party vendors must have a financial incentive in order to participate in the program, allowing vendors to charge physician practices administrative fees would add new, potentially significant increased costs to physicians in acquiring and providing treatments to patients without adequate changes to the reimbursement model to compensate for these costs.”
The AMA said that lower reimbursement combined with administrative fees would likely make the model untenable for physician practices unless changes to the reimbursement model were made.
The AMA also took issue with the focus on single-source drugs and biologics indexed with international pricing, which could create access issues.
“We urge CMS to undertake modeling and simulation of the impact if vendors are unable to obtain these drugs at the reimbursement amount,” the AMA stated in its comment letter. “There is a distinct possibility of immediate adverse patient impact if none of the vendors are able to secure needed clinical treatments.”