Life Science Compliance Update

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May 11, 2017

MedPAC Approves Part B Payment Recommendations

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In early April, during the first session of the Medicare Payment Advisory Commission’s (MedPAC’s) public meeting, the Commission discussed Medicare Part B drug payment policy issues. During the meeting, the Commission unanimously approved several draft recommendations that are expected to be part of the Commission’s June Report to Congress.

MedPAC staff outlined the policy approach to Part B drug reform that would mirror the approach to Part B physician payment reform enacted under the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). Under the recommendations, there would be two tracks for Part B drug reimbursement: a re-vamped version of the current average sales price (ASP) plus six percent payment, or an updated version of Medicare’s competitive acquisition program (CAP), known as the Drug Value Program (DVP). The basic idea behind this is that, over time, the ASP add-on payment would be reduced to incentivize physician participation in the DVP.

The DVP program would take lessons learned from the CAP program and give the Department of Health and Human Services (HHS) Secretary the authority to use private vendors to negotiate prices and offer providers shared savings opportunities. MedPAC staff noted that DVP would: be voluntary, include multiple vendors, and allow providers to share in savings that Medicare received on the drug’s purchase price. The vendors who negotiated the prices would be paid a fixed administrative fee. Additionally, the DVP would differ from the CAP because vendors would be able to utilize a formulary with an exceptions and appeals process.

Specifically, MedPAC made several recommendations that Congress should change Medicare’s payment for Part B drugs and biologicals. Some of those recommendations are laid out below.  

First, they agreed that the ASP system should be modified in 2018 to: (1) require all manufacturers to submit ASP data, and impose penalties for failure to report; (2) reduce wholesale acquisition cost (WAC)-based payment to WAC plus 3 percent; (3) require manufacturers to pay Medicare a rebate when the ASP for their product reaches an inflation benchmark, and tie beneficiary cost sharing and the ASP add-on to the inflation adjusted ASP; and (4) require the HHS Secretary to use a common billing code to pay for a reference biologic and its biosimilars.

They also agreed to create and phase in a voluntary Drug Value Program (DVP) with the following mandatory elements (no later than 2022): (1) Medicare contracts with a small number of private vendors to negotiate prices for Part B products; providers purchase all DVP products at the price negotiated by their selected DVP vendor; (3) Medicare pays providers the DVP-negotiated price and pays vendors an administrative fee, with opportunities for shared savings; (4) beneficiaries pay lower cost-sharing; (5) Medicare payments under the DVP cannot exceed 100 percent of ASP; and (6) vendors use tools including a formulary and, for products meeting selected criteria, binding arbitration.

While MedPAC Commissioners voted in favor of the reforms discussed above, the stability of pricing within the Part B drug marketplace remained a concern. The Commissioners also pressed MedPAC staff for specific numbers regarding inflation caps, DVP incentives, and penalties for failing to report ASP data. Chairman Jay Crosson and Commissioner Paul Ginsburg of the Brookings Institution called the reforms a step in the right direction, noting that the proposals strengthen the market dynamics for Part B Drugs. Commissioner Ginsburg also praised inflation adjustment caps as a means for suppressing the continuing price increases for Part B drugs.

Commissioner Amy Bricker of Express Scripts noted that she supports “roughly 80%” of the draft recommendations, but expressed three concerns with provisions put forward by the Commission. Commissioner Bricker strongly opposed the arbitration provision of the DVP, noting that it’s “contradictory to the free market emphasis” MedPAC aims to achieve through these reforms, as well as disagreeing with other Commissioners regarding inflation caps and consolidated billing codes for biosimilars. Commissioner Bricker and Commissioner Alice Coombs of South Shore Hospital also questioned MedPAC staff about administrative costs for drug administration, stressing the importance of minimizing the burdens of these costs.

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