ATAP SPOTLIGHT: Judith Gorsuch, J.D., VP and Counsel, Hart Health Strategies, Inc.

ATAP SPOTLIGHT is on Judith Gorsuch, J.D., Vice President and Counsel, Hart Health Strategies, Inc. who has written a synopsis of some of ATAP’s past endeavors:

In recent years, policymakers at all levels of government have begun to increase transparency and accountability for PBMs. The Centers for Medicare and Medicaid Services (CMS) proposed several transparency-focused policies, which ATAP commented on from its unique perspective as a multispecialty, single-issue-driven coalition of patients and providers. This included, for example, providing context on proposed data content elements for disclosing meaningful price and cost information to patients and supporting CMS’ proposal to require disclosure of prerequisites to coverage. Conversely, CMS also proposed policies that would empower insurers at the expense of patients. ATAP pushed back against these, including limitations on the availability of copay assistance programs, the creation of a specialty tier in Part D, and allowing PBMs to participate in Importation Programs. The most meaningful regulation came from the Office of the Inspector General, which proposed elimination of the antikickback law exemption for the payments from manufacturers to PBMs. ATAP commented in strong support of this regulation, which was finalized and became the immediate subject of a lawsuit by the PBM industry. The Biden Administration has delayed the regulation’s effective date, but, thus far, has not abandoned it. ATAP should be ready to strongly push back against such a reversal, should it occur.

Meanwhile, the judicial branch involved itself on the topic of PBMs at the highest level, with the Supreme Court unanimously siding with Arkansas in Rutledge v. Pharmaceutical Care Management Association. The Court held that the federal statute ERISA did not preempt an Arkansas law regulating pharmacy fees, which lays the groundwork for States to pursue further PBM-related legislation. ATAP’s amicus brief provided the Court with an overview of the misaligned incentives in the current supply chain and the effect on patients and clinicians across all disease states and specialties that rely on highly rebated drugs.

Congress is currently returning to the issue of drug pricing, with two partisan comprehensive drug pricing reform bills introduced in the House and a lengthy legislative hearing held in the House Energy & Commerce Committee on May 4. Only one of the comprehensive reform bills, HR19, includes provisions related to PBMs. On the Senate side, there was some bipartisan momentum on the topic of drug pricing reform last Congress, but it remains to be seen whether the spirit of bipartisanship will result in a compromise legislative product in that chamber this session. For now, both Senate Republicans and Democrats are working on their own drug pricing proposals, making this an ideal time for ATAP to engage anew in the federal debate on drug pricing reform.