Title: 5 Health Care Policy Issues To Follow In 2018 - Law360
Headings: 5 Health Care Policy Issues To Follow In 2018
5 Health Care Policy Issues To Follow In 2018
Content: While the parties have generally not been aligned on drug pricing reforms, proposals aimed at increasing competition have attracted bipartisan interest. The U.S. Food and Drug Administration Reauthorization Act of 2017, which nearly unanimously passed both chambers, codified an expedited pathway for certain generics if the secretary determines that there is "inadequate generic competition." Additionally, during a recent Senate Health, Education, Labor, and Pensions Committee hearing, bipartisan members voiced support for addressing anti-competitive practices in bringing generics and biosimilars to the market, as well as prohibiting pay-for-delay agreements. 340B Drug Pricing Program
2018 could be the year that Congress enacts reforms to the 340B Drug Pricing Program. Over the past several years, the 340B program has been marked by considerable uncertainty, driven, in part, by tension over the intent of the program and debate over the Health Resources and Services Administration 's (HRSA) oversight and regulatory authority over the program. The House Energy & Commerce Committee has taken the lead on 340B reform, with its Oversight Subcommittee expected to release a report on 340B early next year. Committee members, Reps. Chris Collins, R-N.Y., and Buddy Carter, R-Ga., have been developing comprehensive 340B reform legislation, which could codify many unresolved issues, including the scope of HRSA's oversight and regulatory authority, the definition of a "patient," and the original intent of the 340B program. More immediately, if not addressed before the end of this year, we anticipate efforts to roll back CMS's 2018 outpatient prospective payment system (OPPS) final rule, which starting on Jan. 1, 2018, will reduce reimbursement for certain separately payable, non-pass through Part B drugs purchased under the 340B program.