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The Centers for Medicare & Medicaid Services in October 2018 issued an ”advance notice of proposed rulemaking with comment” outlining a test that would pay for Part B drugs with price points more closely aligned with international rates through the use of private sector vendors that would negotiate drug prices, procure the products, distribute them to physicians and hospitals, and take on the responsibility of billing Medicare.
Although the so-called International Pricing Index (IPI) model is not fully fleshed out in the regulatory filing, one of the key details that has been announced is that the demonstration project would have mandatory participation. This did not sit well with medical societies offering feedback to CMS.
The American Gastroenterological Association stated in comments filed with the agency that “AGA opposes mandatory physician participation and we urge CMS to implement the model on a voluntary basis.” AGA further noted that, while they support the Administration’s goal of reducing drug costs, “we are concerned that the model, as described, will make acquisition of Part B drugs more complex and will shift costs to physicians and practices, increasing administrative burden. Moreover, we are concerned that the IPI model may restrict access to clinically appropriate therapies for people with digestive diseases.”
And while the Community Oncology Alliance also spoke against making participation in the IPI model demonstration project mandatory, it went further with its criticism of the proposal.
“COA does not support the IPI Model as proposed in the pre-proposed rule published by [CMS] because we have serious concerns about its impact on cancer patient care and even its legality,” the group said on Dec. 31, 2018, comments filed with the agency, adding that “mandatory demonstration projects are clearly not in the charter of CMMI [Center for Medicare & Medicaid Innovation] as written into law by Congress. ... That would either be illegal or unconstitutional, with the latter case invalidating the section of the law that created and funded CMMI.”
The AGA, like other groups, also took exception to CMS’s “insinuation” in its regulatory preproposal that physicians select treatments based on reimbursement ahead of patient need. “CMS has repeatedly suggested that physicians prescribe therapies to patients not based on clinical evidence and judgment, but rather based on how much Medicare revenue it will generate for them. AGA objects to this premise. There is no objective evidence to support this idea.”
While none of the groups offered support for the IPI demonstration project, all offered suggestions on what could be done to improve on the details outlined in the advanced noticed of proposed rulemaking. AGA made recommendations, including making IPI Model participation voluntary; allowing individual physicians and physician groups to become model vendors, even if they intend to serve only their own practice or their own geographic region; prohibiting model vendors from implementing utilization management; and making model vendors responsible for collecting beneficiary cost-sharing. The American Medical Association in Dec. 20, 2018, comments to the agency took issue with the focus on single-source drugs and biologics indexed with international pricing, which could create access issues and have immediate adverse patient impacts.
