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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 College of Rheumatology stated in comments filed with the agency that “we do not support mandatory demonstration projects.”
The American Society of Clinical Oncology echoed that sentiment in Dec. 31, 2018, comments filed with the agency. “ASCO cannot support a mandatory demonstration program,” the group noted. “We are concerned about losing access points to oncology care provided by oncology practices, especially in rural, underserved, and low-income areas that are already struggling to deliver care.”
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 in 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. If CMS believes that CMMI has the power via statute to effectively amend Medicare law – in this case the Part B drug reimbursement rate for at least 50% of Part B providers – it (CMS representing the Executive branch) either has overstepped its constitutional boundaries separating the powers of government branches or Congress has effectively handed over its powers to the Executive branch. That would either be illegal or unconstitutional, with the latter case invalidating the section of the law that created and funded CMMI.”
While none of the groups offered support to the IPI demonstration project, all offered suggestions on what could be done to improve on the details outlined in the advance notice of proposed rulemaking.